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OAM001604

by Quanta System SpA

OAM001604 is a Class II device made by Quanta System SpA, listed in FDA GUDID since 5 Sep 2016 (UDI-DI 08033945935900), 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 Number08033945935900 UDI-DI Date5 Sep 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  • Withdrawn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
Light-energy skin surface treatment system applicator
Model / reference
OAM001604
Primary DI / UDI-DI
08033945935900
FDA product code
GEX
GMDN term
Light-energy skin surface treatment system applicator
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Light-energy skin surface treatment system applicator

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)