Consulting Wallah › Device Explorer › Other devices › Radio-frequency skin surface treatment system
Device Explorer · FDA GUDID · GMDN 58454

Radio-frequency skin surface treatment system

An assembly of devices designed to apply radio-frequency (RF) energy to heat the skin surface for ablation, coagulation, and tightening of the skin’s outer later (stratum corneum) for aesthetic skin resurfacing. It primarily consists of a mains electricity (AC

US‑registered devices67in commercial distribution
Companies11labelers on GUDID
Single‑use25%of device records
Sterile24%labelled sterile
Prescription70%Rx‑only share
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Share of device records

Lutronic Corporation2334%
Venus Concept Ltd1421%
Shenb Co., Ltd.1116%
Inmode M.D Ltd46%
Pollogen Ltd46%
Home Skinovations Ltd46%
El Global Trade Ltd34%
Intelis Instruments Ltd11%

Top labelers

CompanyDevicesShare
Lutronic Corporation2334%
Venus Concept Ltd1421%
Shenb Co., Ltd.1116%
Inmode M.D Ltd46%
Pollogen Ltd46%
Home Skinovations Ltd46%
El Global Trade Ltd34%
Intelis Instruments Ltd11%
Viora Ltd11%
Isomers Laboratories Inc11%
Ilooda.Co.,Ltd11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ReversoV10 ConsolePlusMiniFXBodyFXPOLLOGEN LEGENDVenus Viva system - NikaoVenus Viva GLB Diamondpolar applicator spare parVenus Viva GLB applicator spare parts packageVenus Viva GLB packageVenus Viva GLB Diamondpolar applicatorVenus Viva GLB applicatorVenus Vila GLB systemVenus Viva - Diamondpolar applicatorVenus Viva kitVenus Viva

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

FDA product codes

CodeNameDevices
GEIElectrosurgical, Cutting & Coagulation & Accessories52
OUHSkin Resurfacing Rf Applicator6
PBXMassager, Vacuum, Radio Frequency Induced Heat5
PAYOver-The-Counter Radiofrequency Coagulation Device For Wrink5
OHSLight Based Over The Counter Wrinkle Reduction4
ISAMassager, Therapeutic, Electric3

GMDN & GCC registration

  • GMDN code 58454 · non‑implantable
  • Single‑use 25% · sterile 24% · Rx‑only 70% · OTC 10%
  • 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 radio-frequency skin surface treatment system products are registered in the US?

67 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radio-frequency skin surface treatment system", from 11 companies. The largest labeler is Lutronic Corporation with 34% of records.

Which FDA product codes apply?

GEI (Electrosurgical, Cutting & Coagulation & Accessories), OUH (Skin Resurfacing Rf Applicator), PBX (Massager, Vacuum, Radio Frequency Induced Heat), PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrink)

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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