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Device Explorer · FDA GUDID · GMDN 36775

Skin laser scanner

An electromechanical device intended to enable a laser beam, produced by an appropriate laser, to be scanned uniformly over a broad field of skin, typically for the removal of skin lesions (e.g., birthmarks, pigmentations) and tattoos. A laser beam is typicall

US‑registered devices65in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Fisioline Srl4468%
Lumenis Be Ltd1117%
Quanta System Spa58%
Deka M.E.L.A. Srl35%
Btl Industries Limited23%

Top labelers

CompanyDevicesShare
Fisioline Srl4468%
Lumenis Be Ltd1117%
Quanta System Spa58%
Deka M.E.L.A. Srl35%
Btl Industries Limited23%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AcuScan120™ Microscanner Kit, Field UpgradeUltraScan CPGDeepFX™ MicroscannerDeepFX ™ MicroscannerAcuScan120™ Microscanner KitAcuScan™120 Microscanner Kit, UpgradeSurgiTouch™ ScannerSurgiTouch Scanner KitScanning System for LS-6000EMVITAL Hands-Free ApplicatorOptiscan PRIMEOptiScanLUMIXCPS2HPLUMIX 250LUMIX 100LUMIX ULTRA/PLUS

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

FDA product codes

CodeNameDevices
ILYLamp, Infrared, Therapeutic Heating46
GEXPowered Laser Surgical Instrument19

GMDN & GCC registration

  • GMDN code 36775 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 94% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Lumen/Inner Diameter (Nanometer) · 146Lumen/Inner Diameter (Millimeter) · 44

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

How many skin laser scanner products are registered in the US?

65 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Skin laser scanner", from 5 companies. The largest labeler is Fisioline Srl with 68% of records.

Which FDA product codes apply?

ILY (Lamp, Infrared, Therapeutic Heating), 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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