Consulting Wallah › Device Explorer › Other devices › General/multiple surgical solid-state laser system
Device Explorer · FDA GUDID · GMDN 36170

General/multiple surgical solid-state laser system

A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedi

US‑registered devices278in commercial distribution
Companies25labelers on GUDID
Single‑use21%of device records
Sterile15%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Lumenis Ltd.9333%
Quanta System Spa186%
Ceramoptec Gmbh176%
Gyrus Acmi, Llc176%
Laseroptek Co.,Ltd176%
Ipg Medical Corporation166%
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.114%
C. R. Bard, Inc.114%

Top labelers

CompanyDevicesShare
Lumenis Ltd.9333%
Quanta System Spa186%
Ceramoptec Gmbh176%
Gyrus Acmi, Llc176%
Laseroptek Co.,Ltd176%
Ipg Medical Corporation166%
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.114%
C. R. Bard, Inc.114%
Leoni Fiber Optics Gmbh104%
Lutronic Corporation104%
Asclepion Laser Technologies Gmbh93%
Lisa Laser Products Gmbh62%

Company = labeler of record on GUDID. 25 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Lumenis Pulse 60H, 60HzLumenis Pulse 30HVersaPulse PowerSuite 100WLumenis Pulse P120 30 AmpLumenis Pulse 60H, 50HzLumenis Pulse 120HLumenis Pulse 50HLumenis Pulse 100HLumenis Pulse, Moses 2.0 (INT)Lumenis Pulse, Moses 2.0 (DOM)VersaPulse P20VersaPulse PowerSuite 60WVersaPulse PowerSuite 80/100WVERSAPULSE P20VersaPulse PowerSuiteVersaPulse Powersuite

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 Instrument287
GEXPowered laser surgical instrument47
PDZLasers For Temporary Increase Of Clear Nail In Patients With10
GCJLaparoscope, General & Plastic Surgery7
NVKLaser, Dental, Soft Tissue7
ILYLamp, Infrared, Therapeutic Heating7

GMDN & GCC registration

  • GMDN code 36170 · non‑implantable
  • Single‑use 21% · sterile 15% · Rx‑only 94% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Kilogram) · 2

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

How many general/multiple surgical solid-state laser system products are registered in the US?

278 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General/multiple surgical solid-state laser system", from 25 companies. The largest labeler is Lumenis Ltd. with 33% of records.

Which FDA product codes apply?

GEX (Powered Laser Surgical Instrument), GEX (Powered laser surgical instrument), PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With), GCJ (Laparoscope, General & Plastic Surgery)

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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