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Foreo, Inc.

10 FDA records filed under this company name, from 2016 to 2026, in light for wrinkles (OHS, 3), hair growth (OAP, 1), rf for wrinkles (PAY, 2), microcurrent and ems (NFO, 2), hair removal (OHT, 1), light for acne (OLP, 1).

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, 3)

510(k) cleared

FAQ™ (LED Panel); FAQ™ (Dual LED Panel)

510(k) number
K253683
Applicant
Foreo, Inc.
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
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

Luna 4 plus

510(k) number
K241102
Applicant
Foreo, Inc.
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
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

FAQ™ 201, FAQ™ 202

510(k) number
K240378
Applicant
Foreo, Inc.
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“FAQ™ 201 and 202 devices are intended to use LED light for the treatment of wrinkles and 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)

Laser and LED hair-growth caps, helmets and combs (1 record says prescription use) (OAP, 1)

510(k) cleared

FAQ™ (302)

510(k) number
K242747
Applicant
Foreo, Inc.
Product code
OAP: Laser, Comb, Hair
Regulation
21 CFR 890.5500, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The statement's clinical classification text (such as Norwood-Hamilton or Ludwig-Savin ranges) doesn't read cleanly, so we don't quote it rather than guess at a correction. Read FDA's PDF, page 4.

FDA database recordFDA document (PDF)

At-home radiofrequency (RF) wrinkle devices (PAY, 2)

510(k) cleared

FAQ™ (102)

510(k) number
K240616
Applicant
Foreo, Inc.
Product code
PAY: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Regulation
21 CFR 878.4420, 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

FAQ 101

510(k) number
K222012
Applicant
Foreo, Inc.
Product code
PAY: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Regulation
21 CFR 878.4420, 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)

Electrical stimulation for aesthetic use (microcurrent and EMS) (NFO, 2)

510(k) cleared

BEAR 2 Body

510(k) number
K232242
Applicant
Foreo, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.”

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

BEAR and BEAR mini

510(k) number
K200803
Applicant
Foreo, Inc.
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, 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)

Laser and IPL hair removal (mostly over-the-counter; 1 record says prescription use) (OHT, 1)

510(k) cleared

PEACH 2, PEACH 2 Duo, PEACH 2 go

510(k) number
K231977
Applicant
Foreo, Inc.
Product code
OHT: Light Based Over-The-Counter Hair Removal
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“PEACH 2, PEACH 2 Duo and PEACH 2 Go are over-the-counter device intended for the removal of unwanted body hair and/or facial hair.”

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

FDA database recordFDA document (PDF)

LED and light devices for acne (OLP, 1)

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)