Consulting Wallah › Device Explorer › Other devices › Ultraviolet phototherapy unit, home-use
Device Explorer · FDA GUDID · GMDN 34669

Ultraviolet phototherapy unit, home-use

An electrically-powered portable device that includes a lamp which emits light in the ultraviolet (UV) band intended to be used in the home to treat dermatological disorders (e.g., psoriasis, dermatitis) and/or to stimulate the production of endogenous vitamin

US‑registered devices118in commercial distribution
Companies6labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription87%Rx‑only share
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Share of device records

National Biological Corporation5345%
Xuzhou Kernel Medical Equipment Co., Ltd.2925%
Solarc Systems Inc2521%
Solius Labs, Inc.87%
Ultralite Enterprises Inc22%
Medtek Lighting Corporation11%

Top labelers

CompanyDevicesShare
National Biological Corporation5345%
Xuzhou Kernel Medical Equipment Co., Ltd.2925%
Solarc Systems Inc2521%
Solius Labs, Inc.87%
Ultralite Enterprises Inc22%
Medtek Lighting Corporation11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

KernelSoliusPanosol 6-3DPanosol 6National Biological Corporation4-Lamp 2' PanosolHouva-NET Control SystemHandisolUVBioTekPanelite Unit, 12 Visible Lamp UnitPanelite Home Unit, 8 UVB LampsSolarc/SolRx E-SeriesSolarc/SolRx 100-SeriesSolarc/SolRx 500-SeriesSolarc/SolRx 1000-Series

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, Dermatological108
IOBLamp, Infrared, Non Heating10
SGZUltraviolet Lamp Products8

GMDN & GCC registration

  • GMDN code 34669 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 87% · OTC 7%
  • 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) · 1Weight (Pound) · 1

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

How many ultraviolet phototherapy unit, home-use products are registered in the US?

118 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ultraviolet phototherapy unit, home-use", from 6 companies. The largest labeler is National Biological Corporation with 45% of records.

Which FDA product codes apply?

FTC (Light, Ultraviolet, Dermatological), IOB (Lamp, Infrared, Non Heating), SGZ (Ultraviolet Lamp Products)

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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