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Coolite BOLT

by Shenzhen GSD Tech Co., Ltd.

Ref GP900A8

Coolite BOLT (GP900A8) is a dermatological diode laser system (EU MDR Class IIa; FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Shenzhen GSD Tech Co., Ltd., registered in EUDAMED on 20 Sep 2022 (Basic UDI-DI 69282580GP900SERIES7Z), cleared under FDA 510(k) K213225 on 22 Dec 2021 and listed in FDA GUDID since 30 Sep 2024 (UDI-DI 06928258000815), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213225

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06928258000815 UDI-DI Date30 Sep 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69282580GP900SERIES7Z Basic UDI-DI 06928258000815UDI-DIDate20 Sep 2022RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213225 Date22 Dec 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69282580GP900SERIES7Z registered 20 Sep 2022 Active
  • FDA 510(k) K213225 decided 22 Dec 2021 Active
  • FDA GUDID UDI-DI 06928258000815 listed 30 Sep 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K213225
  2. Registered EUDAMED 69282580GP900SERIES7Z
  3. Listed FDA GUDID 06928258000815

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Coolite BOLT EUDAMED
Gsd GUDID
Generic name
Dermatological diode laser system
Device name
Diode Laser System
Model / reference
GP900A8
Primary DI / UDI-DI
06928258000815 EUDAMED
06928258000846 GUDID
Basic UDI-DI
69282580GP900SERIES7Z
Direct marketing DI
06928258000815
510(k) Number
FDA product code
GEX
EMDN code
Z12040202 Phototherapy equipment
GMDN term
Dermatological diode laser system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06928258000815
GUDID
06928258000846
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06928258000815; FDA GUDID lists 06928258000846), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CN-MF-000002168
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

From the manufacturer

Manufacturer's product page: Coolite BOLT

Related devices

Category: Red-light phototherapy unit, professional

Similar devices in this category

Other devices filed under PHOTOTHERAPY EQUIPMENT.

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

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)