Smart Beauty Devices

Home / Device types / Light for acne

LED and light devices for acne

Records FDA files under its code for over-the-counter light-based acne devices. Most are blue or blue-and-red LED masks, patches and wands; individual records can list other or additional uses.

51 records from 2009 to 2026, filed by 43 companies. 8 of the device names as filed include the word "mask". We quote the indications for use for 22 of them from FDA's PDFs.

What FDA's code OLP covers

FDA device name
“Over-The-Counter Powered Light Based Laser For Acne”
FDA definition
“The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.”
Physical state
“Light Source”
Technical method
“The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth.”
Target area
“Mainly on the face, but can be on the back or on the other parts of the body. Treatment area is 5x6 cm (at a time.)”
Regulation
21 CFR 878.4810: “Laser surgical instrument for use in general and plastic surgery and in dermatology.” This regulation covers laser and light instruments for general and plastic surgery and dermatology broadly; the product code is what narrows it to over-the-counter use.
Device class
Class II

Quoted from FDA's Product Classification database entry for OLP, checked October 12, 2026.

All 51 records, newest first

Each record is one FDA decision about the device named in it, for the use in its indications statement. The company that filed may be the brand on the box or the manufacturer that makes it for the brand.

Records are grouped by FDA product code; a record's own indications can be narrower, broader or different from the group name, so read each one. We quote an indications statement only when it comes from a text page of FDA's PDF (not a scan) and every word checks out; otherwise the entry says why and links the PDF, which is the authority.

2026202520232022202120202019201820172016201520142013201220102009

2026 (1)

2025 (3)

510(k) cleared

Erchonia EVRL

510(k) number
K251843
Applicant
Erchonia Corporation
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Erchonia EVRL is intended to emit energy in the red and blue region of the spectrum, and is specifically indicated to treat mild to moderate acne.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

LED Light Therapy Mask (RT01)

510(k) number
K242068
Applicant
Ningbo Dechang Electrical Machinery Made Co.,Ltd
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The LED Light Therapy Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask is an over-the-counter device intended to emit energy in the red and Near Infrared spectrum and is intended for the use in the treatment of full-face wrinkles.”

Copied from the text of FDA's 510(k) document (PDF, page 7), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)

510(k) number
K243555
Applicant
Shenzhen Eyco Technology Co., Ltd.
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)

2023 (3)

510(k) cleared

BLU TOTALE (Model: ENEOB852)

510(k) number
K232656
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)

510(k) cleared

PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT

510(k) number
K230490
Applicant
Dongguan Hunter Electronic Technology Co., Ltd.
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The pmd clean acne is intended for over-the-counter use to treat mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001

510(k) number
K230720
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001, PR5001) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

2022 (5)

510(k) cleared

LED Facial Mask

510(k) number
K213056
Applicant
Shenzhen Osto Technology Company Limited
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.

FDA database recordFDA document (PDF)

510(k) cleared

The Luminance RED Acne Device

510(k) number
K220729
Applicant
Luminance Medical Ventures, Inc.
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)

510(k) cleared

Micro-current facial cold and hot service (model: TPML-100)

510(k) number
K213039
Applicant
Li-Tek Electronics Technology C0., Ltd.
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.

FDA database recordFDA document (PDF)

510(k) cleared

Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine

510(k) number
K210545
Applicant
Marci Beauty, Inc.
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.

FDA database recordFDA document (PDF)

510(k) cleared

Shani Darden LED light therapy mask

510(k) number
K214103
Applicant
Harpar Grace International
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.

FDA database recordFDA document (PDF)

2021 (6)

510(k) cleared

reVive Light Therapy Essentials

510(k) number
K210968
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The reVive Light Therapy® Essentials is an Over the Counter (OTC) LED device intended for use in treating mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

MZ Skin LightMAX Supercharged LED Mask 2.0

510(k) number
K213184
Applicant
Mz Skin
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)

510(k) cleared

DemarkQ WOW, DemarkQ POP

510(k) number
K203214
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

Omnilux CLEAR

510(k) number
K210948
Applicant
Globalmed Technologies
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)

510(k) cleared

Looper (Model: ZX-579S)

510(k) number
K202055
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 3.

FDA database recordFDA document (PDF)

2020 (1)

510(k) cleared

PDT-FACE

510(k) number
K192295
Applicant
Beijing Adss Development Co., Ltd.
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne. The device is indicated for adults only.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

2019 (2)

510(k) cleared

Poly Clear

510(k) number
K183708
Applicant
Medtek Skincare, LLC
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Poly Clear combination of Red (633nm±10nm) and Blue (417nm±10nm) is intended to emit energy in the red, blue regions of the light spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

dpl SpotLite

510(k) number
K183118
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The dpl® SpotLite is an Over-the-Counter (OTC) device intended for use in treatment of mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 7), with line breaks removed.

FDA database recordFDA document (PDF)

2018 (5)

510(k) cleared

LYFT

510(k) number
K180888
Applicant
Uplevity, Inc.
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)

510(k) cleared

LED Light Therapy Device

510(k) number
K180900
Applicant
Uvbiotek, LLC
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)

510(k) cleared

Neutrogena Light Therapy Acne Mask+

510(k) number
K180847
Applicant
Johnson & Johnson Consumer, Inc.
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Neutrogena Light Therapy Acne Mask+ is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

reVive Light Therapy LED Cleansing System

510(k) number
K180447
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) device intended for use in treatment of mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

SAPPHIRE, ELEVARE SAPPHIRE

510(k) number
K172555
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The SAPPHIRE is an over –the -counter hand held, battery operated, light therapy device that uses light emitting diodes (LEDs) that emit a specific wavelength of 415nm (Blue Light) that is intended for use in the treatment of mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

2017 (4)

510(k) cleared

Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)

510(k) number
K161434
Applicant
Li-Tek Electronics Technologies
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is intended for over-the-counter use. LED functional mode - To emit energy in the blue and red region of the spectrum, specifically to treat mild to moderate acne on the face. - To emit energy in the blue region of the spectrum to treat mild to moderate inflammatory acne. Vibrating massage functional mode As an electrically powered device intended for medical purposes to relieve minor aches and pains.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37

510(k) number
K170111
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)

510(k) cleared

BC-001+ Acne Purifier

510(k) number
K170260
Applicant
Oriental Inspiration Limited
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“BC-001+ Acne Purifier is intended/indicated for over-the-counter use in the treatment of mild to moderate acne.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

LED Phototherapy Device

510(k) number
K162098
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the treatment of the mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

FDA database recordFDA document (PDF)

2016 (6)

510(k) cleared

Pulsaderm ACE-All Blue

510(k) number
K162371
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)

510(k) cleared

ESPADA Acne-Clearing Blue Light Pen

510(k) number
K162450
Applicant
Foreo, Inc.
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

Pulsaderm Acne Device

510(k) number
K161941
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“Pulsaderm Acne Device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

Acne Light Therapy Wand

510(k) number
K160691
Applicant
Zuko, Inc.
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Acne Light Therapy Wand is indicated to treat mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

Tria Sapphire

510(k) number
K160821
Applicant
Tria Beauty, Inc.
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Tria Sapphire is indicated for the treatment of mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

Clear Bi-Light

510(k) number
K153081
Applicant
Michael Todd, LP
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Clear Bi-Light is indicated for the treatment of mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

2015 (3)

510(k) cleared

SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS

510(k) number
K152889
Applicant
Biorenew Labs, LLC
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Sonilase Blue is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in the treatment of mild to moderate acne vulgaris. The Sonilase Blue-UV Clean is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in the treatment of mild to moderate acne vulgaris. The Sonilase Blue-UV Clean Plus is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in the treatment of mild to moderate acne vulgaris.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

510(k) cleared

Nutra Light Advanced

510(k) number
K150370
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The statement contains words we couldn't confirm (a typo, run-together words or a reading error), and we don't correct FDA's text. Read FDA's PDF, page 3.

FDA database recordFDA document (PDF)

510(k) cleared

LightStim for Acne/ LightStim for Acne Mini

510(k) number
K142246
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“LightStim for Acne/ LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

2014 (3)

510(k) cleared

ULTRA RENEW PLUS

510(k) number
K132833
Applicant
Accord Media
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)

510(k) cleared

NUTRA LIGHT BLUE

510(k) number
K132838
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 6.

FDA database recordFDA document (PDF)

510(k) cleared

LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI

510(k) number
K131461
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 2.

FDA database recordFDA document (PDF)

2013 (3)

510(k) cleared

ILLUMASK ACNE LIGHT THERAPY MASK

510(k) number
K123999
Applicant
La Lumiere, LLC
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)

510(k) cleared

TANDA MINI SKINCARE SYSTEM

510(k) number
K124042
Applicant
Syneron Beauty
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 2.

FDA database recordFDA document (PDF)

510(k) cleared

SILKN BLUE

510(k) number
K121435
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 1.

FDA database recordFDA document (PDF)

2012 (2)

510(k) cleared

CLEARFLASH AC2100 COSMETIC SYSTEM

510(k) number
K111937
Applicant
Clearflash Technologies, Inc.
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 2.

FDA database recordFDA document (PDF)

510(k) cleared

QUASAR CALYPSO

510(k) number
K111286
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 6.

FDA database recordFDA document (PDF)

2010 (3)

510(k) cleared

NO!NO! SKIN

510(k) number
K102477
Applicant
Radiancy (Israel) , Ltd.
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 6.

FDA database recordFDA document (PDF)

510(k) cleared

QUASAR BLUE LIGHT THERAPY SYSTEM

510(k) number
K093963
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 1.

FDA database recordFDA document (PDF)

510(k) cleared

CLARO

510(k) number
K090744
Applicant
Clrs Technology Corporation
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 2.

FDA database recordFDA document (PDF)

2009 (1)

510(k) cleared

OMNILUX CLEAR-U

510(k) number
K081307
Applicant
Photo Therapeutics, Inc.
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database recordFDA document (PDF)