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Quantaforte OAM001904

by Quanta System SpA

Quantaforte OAM001904 is a Class II device made by Quanta System SpA, cleared under FDA 510(k) K152714 on 21 Dec 2015 and listed in FDA GUDID since 29 Aug 2016 (UDI-DI 08033945934743), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K152714

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08033945934743 UDI-DI Date29 Aug 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152714 Date21 Dec 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152714 decided 21 Dec 2015 Active
  • FDA GUDID UDI-DI 08033945934743 listed 29 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K152714
  2. Listed FDA GUDID 08033945934743

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Quantaforte
Generic name
Dermatological diode laser system
Model / reference
OAM001904
Primary DI / UDI-DI
08033945934743
510(k) Number
FDA product code
ONF, GEX
GMDN term
Dermatological diode laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K152714)

Similar devices

Other devices filed under FDA product code ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect).

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)