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Led Technologies, Inc.

12 FDA records filed under this company name, from 2017 to 2022, in light for wrinkles (OHS, 9), light for acne (OLP, 3).

The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.

LED and light devices for wrinkles (OHS, 9)

510(k) clearedDec 21, 2022

reVive Light Therapy® Wrinkle and Acne LED Device

510(k) number: K223482
Applicant: Led Technologies, Inc.
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Nov 18, 2022

Indications for use, as filed

“The reVive Light Therapy® Wrinkle and Acne LED Device is intended for treatment of wrinkles and mild to moderate inflammatory acne.”

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

FDA database record FDA document (PDF)

510(k) clearedJul 27, 2022

reVive Light Therapy LED Cleansing System

510(k) number: K221430
Applicant: Led Technologies, Inc.
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: May 17, 2022

Indications for use, as filed

“The reVive Light Therapy® LED Cleansing System is intended for treatment of wrinkles and mild to moderate inflammatory acne.”

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

FDA database record FDA document (PDF)

510(k) clearedDec 15, 2021

reVive Light Therapy Essentials

510(k) number: K210965
Applicant: Led Technologies, Inc.
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Mar 31, 2021

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 record FDA document (PDF)

510(k) clearedMar 14, 2019

dpl Faceware

510(k) number: K183247
Applicant: Led Technologies, Inc.
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Nov 21, 2018

Indications for use, as filed

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

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

FDA database record FDA document (PDF)

510(k) clearedMay 15, 2018

reVive Light Therapy LED Ultrasonic Wrinkle System

510(k) number: K180445
Applicant: Led Technologies, Inc.
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Feb 20, 2018

Indications for use, as filed

“The reVive Light Therapy® LED Cleansing System is an Over-the-Counter (OTC) LED device intended for use in treating wrinkles.”

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

FDA database record FDA document (PDF)

510(k) clearedApr 3, 2018

dpl IIa Panel

510(k) number: K180320
Applicant: Led Technologies, Inc.
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Feb 5, 2018

Indications for use, as filed

“The dpl® IIa Panel is an Over-the-Counter (OTC) device intended for use in treating wrinkles, and 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 record FDA document (PDF)

510(k) clearedJan 9, 2018

reVive Perioral

510(k) number: K172662
Applicant: Led Technologies, Inc.
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Sep 5, 2017

Indications for use, as filed

“The reVive® Perioral LED Light Therapy system is an Over-the-Counter (OTC) device intended for the treatment fine lines and wrinkles, and increase in circulation within the perioral region.”

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

FDA database record FDA document (PDF)

510(k) clearedAug 7, 2017

dpl SpectraLite

510(k) number: K171386
Applicant: Led Technologies, Inc.
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: May 11, 2017

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 record FDA document (PDF)

510(k) clearedAug 3, 2017

dpl II Panel

510(k) number: K171390
Applicant: Led Technologies, Inc.
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: May 11, 2017

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 record FDA document (PDF)

LED and light devices for acne (OLP, 3)

510(k) clearedDec 21, 2021

reVive Light Therapy Essentials

510(k) number: K210968
Applicant: Led 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: Mar 31, 2021

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 record FDA document (PDF)

510(k) clearedFeb 7, 2019

dpl SpotLite

510(k) number: K183118
Applicant: Led 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: Nov 9, 2018

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 record FDA document (PDF)

510(k) clearedJun 4, 2018

reVive Light Therapy LED Cleansing System

510(k) number: K180447
Applicant: Led 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: Feb 20, 2018

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 record FDA document (PDF)