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Device Explorer · FDA GUDID · GMDN 65723

Red/infrared light phototherapy unit

An electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modificatio

US‑registered devices247in commercial distribution
Companies33labelers on GUDID
Single‑use7%of device records
Sterile0%labelled sterile
Prescription5%Rx‑only share
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Share of device records

Shenzhen Redv Medical Equipment Co., Ltd6225%
Shenzhen Ais Queen Medical Technology Co., Ltd.208%
Wellness Without Limits Llc166%
Zonnsmart Science & Technology Co.,Ltd146%
Utk Technology(Shenzhen)Limited146%
Sunglor Technology Co., Ltd.135%
Dongguan Redthera Technology Co., Ltd.114%
Shenzhen Idea Light Limited104%

Top labelers

CompanyDevicesShare
Shenzhen Redv Medical Equipment Co., Ltd6225%
Shenzhen Ais Queen Medical Technology Co., Ltd.208%
Wellness Without Limits Llc166%
Zonnsmart Science & Technology Co.,Ltd146%
Utk Technology(Shenzhen)Limited146%
Sunglor Technology Co., Ltd.135%
Dongguan Redthera Technology Co., Ltd.114%
Shenzhen Idea Light Limited104%
Body Balance System, Llc83%
Light Tree Technology India Private Limited83%
I-Smart Developments Limited73%
Merchsource, Llc73%

Company = labeler of record on GUDID. 33 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FlexBeamMarrisJjwSunglorAisQueenN/ATherapy LightLED RED Light Therapy PanelRED Light MaskLED Light Therapy Eye MaskLED Light Therapy Neck MaskRED Light BulbLED RED LIGHTQuasar MDZONNmitoredlightNA

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

FDA product codes

CodeNameDevices
ILYLamp, Infrared, Therapeutic Heating267
OHSLight Based Over The Counter Wrinkle Reduction7
ISAMassager, Therapeutic, Electric5
OLIFat Reducing Low Level Laser4
GEXPowered Laser Surgical Instrument1

GMDN & GCC registration

  • GMDN code 65723 · non‑implantable
  • Single‑use 7% · sterile 0% · Rx‑only 5% · OTC 65%
  • 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 red/infrared light phototherapy unit products are registered in the US?

247 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Red/infrared light phototherapy unit", from 33 companies. The largest labeler is Shenzhen Redv Medical Equipment Co., Ltd with 25% of records.

Which FDA product codes apply?

ILY (Lamp, Infrared, Therapeutic Heating), OHS (Light Based Over The Counter Wrinkle Reduction), ISA (Massager, Therapeutic, Electric), OLI (Fat Reducing Low Level Laser)

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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