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Gsd GP666C4

by Shenzhen GSD Tech Co., Ltd.

Gsd GP666C4 is a Class II device made by Shenzhen GSD Tech Co., Ltd., cleared under FDA 510(k) K091664 on 16 Nov 2009 and listed in FDA GUDID since 30 Sep 2024 (UDI-DI 06928258000891), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K091664

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06928258000891 UDI-DI Date30 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK091664 Date16 Nov 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091664 decided 16 Nov 2009 Active
  • FDA GUDID UDI-DI 06928258000891 listed 30 Sep 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K091664
  2. Listed FDA GUDID 06928258000891

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Gsd
Generic name
Intense pulsed light skin surface treatment system
Model / reference
GP666C4
Primary DI / UDI-DI
06928258000891
510(k) Number
FDA product code
ONF
GMDN term
Intense pulsed light skin surface treatment system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Similar devices

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

Other devices from Shenzhen GSD Tech Co., Ltd.

  • Gsd GP908D

    Class II
  • Gsd GP900A

    Class II
  • Gsd GP908B

    Class II
  • Gsd GP900Q

    Class II

See all devices from Shenzhen GSD Tech Co., Ltd. →

Properties

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