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Gsd GP908B

by Shenzhen GSD Tech Co., Ltd.

Gsd GP908B is a Class II device made by Shenzhen GSD Tech Co., Ltd., cleared under FDA 510(k) K202827 on 15 Dec 2020 and listed in FDA GUDID since 30 Sep 2024 (UDI-DI 06928258000860), 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) K202827

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 Number06928258000860 UDI-DI Date30 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK202827 Date15 Dec 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K202827 decided 15 Dec 2020 Active
  • FDA GUDID UDI-DI 06928258000860 listed 30 Sep 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K202827
  2. Listed FDA GUDID 06928258000860

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  • Withdrawn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
Ultraviolet phototherapy unit, professional
Model / reference
GP908B
Primary DI / UDI-DI
06928258000860
510(k) Number
FDA product code
FTC
GMDN term
Ultraviolet phototherapy unit, professional
Device class
Class II
Regulation number
878.4630
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FTC (Light, Ultraviolet, Dermatological).

Other devices from Shenzhen GSD Tech Co., Ltd.

  • Gsd GP666C4

    Class II
  • Gsd GP908D

    Class II
  • Gsd GP900A

    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)