Consulting Wallah › Device Explorer › Other devices › Cosmetic red-light phototherapy system, home-use
Device Explorer · FDA GUDID · GMDN 47704

Cosmetic red-light phototherapy system, home-use

An assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the ho

US‑registered devices164in commercial distribution
Companies22labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

I-Smart Developments Limited3723%
Home Skinovations Ltd2213%
Quasar Bio-Tech Inc.149%
Shenzhen Kaiyan Medical Equipment Co,. Ltd127%
Iluminage Ltd127%
Procter & Gamble Manufacturing Company, The95%
Silkn Beauty Ltd.74%
Omm Imports Inc.74%

Top labelers

CompanyDevicesShare
I-Smart Developments Limited3723%
Home Skinovations Ltd2213%
Quasar Bio-Tech Inc.149%
Shenzhen Kaiyan Medical Equipment Co,. Ltd127%
Iluminage Ltd127%
Procter & Gamble Manufacturing Company, The95%
Silkn Beauty Ltd.74%
Omm Imports Inc.74%
Blublox Pty Ltd74%
Sunplus Led Technology Co., Ltd.64%
Nuface53%
Shenzhen Ulike Smart Electronics Co., Ltd.42%

Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AvologiSilk'nBestqoolRedfymitoredlightUlikeJmoonHOMEDICSSTETIC SENSEIPL Hair removalTRUDERMALELEMIS Red Light MaskfaceLITE PROLumavance LED facemaskPRIORI Next Generation LED FacemaskLUMA PRO Plus

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

FDA product codes

CodeNameDevices
OHSLight Based Over The Counter Wrinkle Reduction94
ONFPowered Light Based Non-Laser Surgical Instrument With Therm37
OHTLight Based Over-The-Counter Hair Removal36
ILYLamp, Infrared, Therapeutic Heating28
OLPOver-The-Counter Powered Light Based Laser For Acne13
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes10

GMDN & GCC registration

  • GMDN code 47704 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 0% · OTC 88%
  • 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.

How many cosmetic red-light phototherapy system, home-use products are registered in the US?

164 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cosmetic red-light phototherapy system, home-use", from 22 companies. The largest labeler is I-Smart Developments Limited with 23% of records.

Which FDA product codes apply?

OHS (Light Based Over The Counter Wrinkle Reduction), ONF (Powered Light Based Non-Laser Surgical Instrument With Therm), OHT (Light Based Over-The-Counter Hair Removal), ILY (Lamp, Infrared, Therapeutic Heating)

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.

How do I get quotes?

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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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