Consulting Wallah › Device Explorer › Other devices › Radio-frequency skin/body contouring system
Device Explorer · FDA GUDID · GMDN 45219

Radio-frequency skin/body contouring system

An assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled s

US‑registered devices150in commercial distribution
Companies19labelers on GUDID
Single‑use39%of device records
Sterile3%labelled sterile
Prescription67%Rx‑only share
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Share of device records

Jeisys Medical Inc.3624%
Solta Medical3020%
Viveve, Inc.139%
Venus Concept Ltd128%
Alma Lasers Ltd.96%
S&M Medical Inc.85%
Neauvia North America, Inc.64%
Cutera, Inc.64%

Top labelers

CompanyDevicesShare
Jeisys Medical Inc.3624%
Solta Medical3020%
Viveve, Inc.139%
Venus Concept Ltd128%
Alma Lasers Ltd.96%
S&M Medical Inc.85%
Neauvia North America, Inc.64%
Cutera, Inc.64%
Bios Srl64%
Venus Concept Inc.53%
Cynosure Lutronic Technology Corporation53%
Lutronic Corporation32%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ST Single Use Tip(MP)2 APPLICATOR SERVICE PACK, Bliss(MP)2 APPLICATOR BLISSVenus Legacy 110V - NikaoVenus Legacy 240V - NikaoVenus Legacy CX - LF2 applicator (new design)Venus Legacy CX - LB2 applicator (new design)Venus Legacy kitVenus LegacyVenus Legacy - 110V SystemLB1 + LF1 kitVIVEVE Return CableVIVEVE Power CordVIVEVE FootswitchUniversal Electrosurgical Pad (3M REF 9160)VIVEVE Console S

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 & Accessories128
PBXMassager, Vacuum, Radio Frequency Induced Heat48
ISAMassager, Therapeutic, Electric43
NUVMassager, Vacuum, Light Induced Heating17
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep He10
GEXPowered Laser Surgical Instrument3

GMDN & GCC registration

  • GMDN code 45219 · non‑implantable
  • Single‑use 39% · sterile 3% · Rx‑only 67% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Millimeter) · 4Depth (Millimeter) · 4Height (Millimeter) · 4Length (Centimeter) · 1Width (Centimeter) · 1Length (Millimeter) · 1

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

How many radio-frequency skin/body contouring system products are registered in the US?

150 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radio-frequency skin/body contouring system", from 19 companies. The largest labeler is Jeisys Medical Inc. with 24% of records.

Which FDA product codes apply?

GEI (Electrosurgical, Cutting & Coagulation & Accessories), PBX (Massager, Vacuum, Radio Frequency Induced Heat), ISA (Massager, Therapeutic, Electric), NUV (Massager, Vacuum, Light Induced Heating)

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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