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Device Explorer · FDA GUDID · GMDN 58935

Intense pulsed light skin surface treatment system

A mains electricity (AC-powered) mobile (on wheels) device designed to produce strong, controlled flashes of filtered light in the wavelength range 400 - 1200nm [intense pulsed light (IPL)] for heat ablation of pigmented skin cells (selective photothermolysis)

US‑registered devices110in commercial distribution
Companies31labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription27%Rx‑only share
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Share of device records

Jeisys Medical Inc.1816%
Spectrum Brands, Inc.1715%
Viora Ltd1615%
El Global Trade Ltd76%
Shandong Huamei Technology Co.,Ltd.65%
Beijing Adss Development Co., Ltd.65%
Shanghai Apolo Medical Technology Co.,Ltd55%
Shenzhen Bosidin Technology Co.,Ltd.55%

Top labelers

CompanyDevicesShare
Jeisys Medical Inc.1816%
Spectrum Brands, Inc.1715%
Viora Ltd1615%
El Global Trade Ltd76%
Shandong Huamei Technology Co.,Ltd.65%
Beijing Adss Development Co., Ltd.65%
Shanghai Apolo Medical Technology Co.,Ltd55%
Shenzhen Bosidin Technology Co.,Ltd.55%
Shenzhen Leaflife Technology Co., Ltd.22%
Shenzhen Qianyu Technology Co., Ltd22%
Beijing Kes Biology Technology Co.,Ltd.22%
Advanced Technology Laser Co.,Ltd.22%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

V-IPL Filter HR-755AC Hand pieceSR Hand pieceHR Hand pieceTrios™V-IPL Small SpotV-IPL Optic set FullV-IPL Optic set BasicV-IPL Optic set ExtendedV-IPL Filter AC-415V-IPL Filter VP-530V-IPL Filter SR-580V-IPL Filter HR-570V-IPL Filter HR-630V-IPL HP FullV- IPL Handpiece

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

FDA product codes

CodeNameDevices
ONFPowered Light Based Non-Laser Surgical Instrument With Therm56
GEXPowered Laser Surgical Instrument43
OHTLight Based Over-The-Counter Hair Removal32
GEXPowered laser surgical instrument1
ONGPowered laser surgical instrument with microbeam\fractional 1

GMDN & GCC registration

  • GMDN code 58935 · non‑implantable
  • Single‑use 3% · sterile 0% · Rx‑only 27% · OTC 32%
  • 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 intense pulsed light skin surface treatment system products are registered in the US?

110 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intense pulsed light skin surface treatment system", from 31 companies. The largest labeler is Jeisys Medical Inc. with 16% of records.

Which FDA product codes apply?

ONF (Powered Light Based Non-Laser Surgical Instrument With Therm), GEX (Powered Laser Surgical Instrument), OHT (Light Based Over-The-Counter Hair Removal), 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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