Identity
- Trade Name
- Coolite BOLT XS EUDAMEDGSD FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Device Name
- Diode Laser System EUDAMED
- Model / Reference
- GP900A8 EUDAMEDGP900Q8 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06928258000839 EUDAMED06928258000853 FDA UDI
- Basic UDI-DI
- 69282580GP900SERIES7Z EUDAMED
- Direct Marketing DI
- 06928258000839 EUDAMED
- 510(k) Number
- K213225 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Dermatological diode laser system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Red-light phototherapy unit, professional
Coolite BOLT XS by Shenzhen GSD Tech Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Manufacturer's product page: Coolite BOLT
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69282580GP900SERIES7Z | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen GSD Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000002168
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 70071582-90f9-4dc0-83a5-4364b1e2c4af 61 fields · synced Jun 18, 2026
- FDA UDI a01da0f8-0433-4f1a-b64b-e9d5740e2d67 33 fields · synced May 29, 2026