Consulting Wallah › Device Explorer › Other devices › Multi-modality skin surface treatment system
Device Explorer · FDA GUDID · GMDN 45220

Multi-modality skin surface treatment system

An electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabr

US‑registered devices499in commercial distribution
Companies43labelers on GUDID
Single‑use15%of device records
Sterile6%labelled sterile
Prescription64%Rx‑only share
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Share of device records

Alma Lasers Ltd.11423%
Lumenis Be Ltd459%
Candela Corporation459%
Cynosure, Llc357%
Solta Medical337%
Espansione Marketing Spa286%
Inmode M.D Ltd265%
Ellipse A/S224%

Top labelers

CompanyDevicesShare
Alma Lasers Ltd.11423%
Lumenis Be Ltd459%
Candela Corporation459%
Cynosure, Llc357%
Solta Medical337%
Espansione Marketing Spa286%
Inmode M.D Ltd265%
Ellipse A/S224%
Advance-Esthetic Llc122%
Inbella Medical Inc122%
Termosalud Sl112%
Viora Ltd102%

Company = labeler of record on GUDID. 43 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Stellar M22™ Q-Switched Nd:YAG Upgrade KitStellar M22™ Multi-Spot™ Nd:YAG Upgrade kitM22™ Q-Switched HeadMulti-Spot™ Nd:YAG HeadStellar XPL Module KitBlack Stellar XPL HPStellar M22™M22™ Q-Switched Lens KitMulti-Spot Nd:YAG Lightguide 1.5mm TipNd:YAG SapphireCool™ Lightguides 9mm KitNd:YAG SapphireCool™ Lightguides 2x4mm KitNd:YAG SapphireCool™ Lightguides 6mm KitM22™ Q-Switched 8mm Metal Treatment Tip KitM22™ Q-Switched 4mm Metal Treatment Tip KitM22™ Q-Switched 2mm Metal Treatment Tip KitM22™ Q-Switched 2.5mm Metal Treatment Tip Kit

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

FDA product codes

CodeNameDevices
GEXPowered Laser Surgical Instrument450
ONFPowered Light Based Non-Laser Surgical Instrument With Therm187
GEIElectrosurgical, Cutting & Coagulation & Accessories134
ONGPowered Laser Surgical Instrument With Microbeam\Fractional 84
GEXPowered laser surgical instrument36
GFEBrush, Dermabrasion, Powered33

GMDN & GCC registration

  • GMDN code 45220 · non‑implantable
  • Single‑use 15% · sterile 6% · Rx‑only 64% · 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

No structured size data on the register.

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

How many multi-modality skin surface treatment system products are registered in the US?

499 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multi-modality skin surface treatment system", from 43 companies. The largest labeler is Alma Lasers Ltd. with 23% of records.

Which FDA product codes apply?

GEX (Powered Laser Surgical Instrument), ONF (Powered Light Based Non-Laser Surgical Instrument With Therm), GEI (Electrosurgical, Cutting & Coagulation & Accessories), ONG (Powered Laser Surgical Instrument With Microbeam\Fractional )

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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