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Device Explorer · FDA GUDID · GMDN 58455

Radio-frequency skin surface treatment system applicator

A handpiece component of a radio-frequency skin surface treatment system designed to be used by a healthcare professional to deliver bipolar radio-frequency (RF) energy to the skin surface for skin resurfacing. It is typically designed to deliver RF energy to

US‑registered devices51in commercial distribution
Companies8labelers on GUDID
Single‑use14%of device records
Sterile4%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Inmode M.D Ltd1937%
Pollogen Ltd1224%
Inbella Medical Inc1122%
Silkn Beauty Ltd.48%
Endymed Medical Ltd24%
Intelis Instruments Ltd12%
Venus Concept Inc.12%
Shenb Co., Ltd.12%

Top labelers

CompanyDevicesShare
Inmode M.D Ltd1937%
Pollogen Ltd1224%
Inbella Medical Inc1122%
Silkn Beauty Ltd.48%
Endymed Medical Ltd24%
Intelis Instruments Ltd12%
Venus Concept Inc.12%
Shenb Co., Ltd.12%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Morpheus8 90 ApplicatorMorpheus8 Burst Deep ApplicatorMorpheus8 Burst ApplicatorMorpheus8C HandpieceOPTILIFT FRACTIONALOptiLIFT ApplicatorReverso ApplicatorEndyMed Pro FSR HandpieceEndyMed Pure FSR HandpieceMorpheus8V ApplicatorTransform (T3 Applicator)Morpheus8 Body (Blue)FormaIFormaV ApplicatorEmBodyFx (Trim) HPEmBodyPlus (Tite) HP

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 & Accessories36
PBXMassager, Vacuum, Radio Frequency Induced Heat11
NGXStimulator, Muscle, Powered, For Muscle Conditioning8
PAYOver-The-Counter Radiofrequency Coagulation Device For Wrink4
OHSLight Based Over The Counter Wrinkle Reduction4
ISAMassager, Therapeutic, Electric3

GMDN & GCC registration

  • GMDN code 58455 · non‑implantable
  • Single‑use 14% · sterile 4% · Rx‑only 88% · OTC 8%
  • 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 applicator products are registered in the US?

51 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 applicator", from 8 companies. The largest labeler is Inmode M.D Ltd with 37% of records.

Which FDA product codes apply?

GEI (Electrosurgical, Cutting & Coagulation & Accessories), PBX (Massager, Vacuum, Radio Frequency Induced Heat), NGX (Stimulator, Muscle, Powered, For Muscle Conditioning), 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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