Skip to content

OAM001198

by Quanta System SpA

OAM001198 is a Class II device made by Quanta System SpA, listed in FDA GUDID since 29 Aug 2016 (UDI-DI 08033945934972), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08033945934972 UDI-DI Date29 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name
Dermatological laser beam guiding handpiece
Model / reference
OAM001198
Primary DI / UDI-DI
08033945934972
FDA product code
GEX
GMDN term
Dermatological laser beam guiding handpiece
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dermatological laser beam guiding handpiece

Similar devices in this category

Other devices filed under Dermatological laser beam guiding handpiece.

Other devices from Quanta System SpA

See all devices from Quanta System SpA →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)