Consulting Wallah › Device Explorer › Other devices › Ultraviolet phototherapy unit, professional
Device Explorer · FDA GUDID · GMDN 35149

Ultraviolet phototherapy unit, professional

A mains electricity (AC-powered) device with special lamps that emit ultraviolet B (UVB), or UVB and ultraviolet A (UVA) radiation intended to be used by a healthcare professional to treat a variety of dermatological disorders (e.g., psoriasis). The device is

US‑registered devices388in commercial distribution
Companies15labelers on GUDID
Single‑use2%of device records
Sterile2%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Daavlin Distributing Co., The29877%
National Biological Corporation318%
Medtek Lighting Corporation123%
Solarc Systems Inc123%
Ultralite Enterprises Inc82%
Corpak Medsystems, Inc.72%
Shenzhen Peninsula Medical Group Co., Ltd.41%
Xuzhou Kernel Medical Equipment Co., Ltd.31%

Top labelers

CompanyDevicesShare
Daavlin Distributing Co., The29877%
National Biological Corporation318%
Medtek Lighting Corporation123%
Solarc Systems Inc123%
Ultralite Enterprises Inc82%
Corpak Medsystems, Inc.72%
Shenzhen Peninsula Medical Group Co., Ltd.41%
Xuzhou Kernel Medical Equipment Co., Ltd.31%
Zerigo Health, Inc.31%
Chongqing Peninsula Medical Technology Co., Ltd.21%
Shenzhen Gsd Tech Co., Ltd.21%
Clarteis21%

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

Brand names on the register (sample)

Boston Aesthetics308nm Excimer SystemAPKKERNELGSDEXCI308 by AerolaseExciplex®Zerigo Handheld SystemClarify MedicalDAAVLINPanosol 6-3DPanosol 6HandisolDermalumePanosol II CabinetNational Biological Corporation

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

FDA product codes

CodeNameDevices
FTCLight, Ultraviolet, Dermatological355
FTCLIGHT, ULTRAVIOLET, DERMATOLOGICAL297
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)7
GEXPowered Laser Surgical Instrument3
MCFUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes1

GMDN & GCC registration

  • GMDN code 35149 · non‑implantable
  • Single‑use 2% · sterile 2% · Rx‑only 97% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Area/Surface Area (Square inch) · 12Weight (Pound) · 12Catheter Gauge (French) · 7

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

How many ultraviolet phototherapy unit, professional products are registered in the US?

388 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ultraviolet phototherapy unit, professional", from 15 companies. The largest labeler is Daavlin Distributing Co., The with 77% of records.

Which FDA product codes apply?

FTC (Light, Ultraviolet, Dermatological), FTC (LIGHT, ULTRAVIOLET, DERMATOLOGICAL), KNT (TUBES, GASTROINTESTINAL (AND ACCESSORIES)), 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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