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Device Explorer · FDA GUDID · GMDN 62116

Red/blue light phototherapy unit

A portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pai

US‑registered devices61in commercial distribution
Companies15labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Shenzhen Sungrow Led Technology Co., Ltd1321%
Tanda Beauty Canada, Inc1220%
Sharkninja Operating Llc1220%
Pulsaderm Llc610%
I-Smart Developments Limited35%
Light Tree Ventures Europe B.V.35%
Joicom Corporation35%
Wellness Without Limits Llc23%

Top labelers

CompanyDevicesShare
Shenzhen Sungrow Led Technology Co., Ltd1321%
Tanda Beauty Canada, Inc1220%
Sharkninja Operating Llc1220%
Pulsaderm Llc610%
I-Smart Developments Limited35%
Light Tree Ventures Europe B.V.35%
Joicom Corporation35%
Wellness Without Limits Llc23%
Beijing Adss Development Co., Ltd.12%
Xplr Ltd12%
Luminance Medical Ventures Incorporated12%
Erchonia Corporation, Llc12%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/APdt-FaceOmnilux Blemish EraserLuma BlemishOmnilux CLEARRENEW Pro Facewear MaskA.C.E Red and BlueBlue LED Acne Clearing LightPulsaderm RED LED Skin RenewalA.C.E BlueLMNTLuminance RED Acne DeviceEVRL-OTCPulsadermLED Blue Acne Clearing MaskLS Pro Systems

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
OLPOver-The-Counter Powered Light Based Laser For Acne52
OHSLight Based Over The Counter Wrinkle Reduction40
OLPOver-the-counter powered light based laser for acne6
GEXPowered Laser Surgical Instrument3
ILYLamp, Infrared, Therapeutic Heating2

GMDN & GCC registration

  • GMDN code 62116 · non‑implantable
  • Single‑use 3% · sterile 0% · Rx‑only 0% · OTC 87%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many red/blue light phototherapy unit products are registered in the US?

61 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Red/blue light phototherapy unit", from 15 companies. The largest labeler is Shenzhen Sungrow Led Technology Co., Ltd with 21% of records.

Which FDA product codes apply?

OLP (Over-The-Counter Powered Light Based Laser For Acne), OHS (Light Based Over The Counter Wrinkle Reduction), OLP (Over-the-counter powered light based laser for acne), GEX (Powered Laser Surgical Instrument)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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