Consulting Wallah › Device Explorer › Dental › Dental solid-state laser system
Device Explorer · FDA GUDID · GMDN 47880

Dental 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 application in dental procedures; it does not include frequency-doubling te

US‑registered devices223in commercial distribution
Companies9labelers on GUDID
Single‑use36%of device records
Sterile0%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Biolase, Inc.15871%
Light Instruments Ltd2612%
Us Endodontics, Llc2511%
Fotona D.O.O.94%
Lightmed Dental Technology Corporation10%
J.Morita Mfg.Corp.10%
Beyond International Inc.10%
Peter Brasseler Holdings, Llc10%

Top labelers

CompanyDevicesShare
Biolase, Inc.15871%
Light Instruments Ltd2612%
Us Endodontics, Llc2511%
Fotona D.O.O.94%
Lightmed Dental Technology Corporation10%
J.Morita Mfg.Corp.10%
Beyond International Inc.10%
Peter Brasseler Holdings, Llc10%
El.En. Spa10%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TIP for LITETOUCHStraight Handpiece, LTE1 Handpiece, LTD-STORMLiteTouch ApplicatorLiteTouchLightMedAdvErL EVOLightWalker ST-E ADVANCEDLightWalker ST-E PROLightWalker AT STimeWalker ST-ETimeWalker ATSkyPulseInPulse Dental LaserEdgePRO™

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 Instrument208
NVKLaser, dental, soft tissue26
NVKLaser, Dental, Soft Tissue1

GMDN & GCC registration

  • GMDN code 47880 · non‑implantable
  • Single‑use 36% · sterile 0% · Rx‑only 95% · 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

Length (Millimeter) · 117Outer Diameter (Micrometer) · 96Lumen/Inner Diameter (Millimeter) · 15Width (Micrometer) · 1

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

How many dental solid-state laser system products are registered in the US?

223 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental solid-state laser system", from 9 companies. The largest labeler is Biolase, Inc. with 71% of records.

Which FDA product codes apply?

GEX (Powered Laser Surgical Instrument), NVK (Laser, dental, soft tissue), NVK (Laser, Dental, Soft Tissue)

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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