Identity
- Trade Name
- TwinScan 808/755 Laser System FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Device Name
- Scanned diode laser 808 nm and 755 nm for hair reduction FDA UDI
- Model / Reference
- 1060 FDA UDI
- Description
- Scanned diode laser 808 nm and 755 nm for hair reduction FDA UDI
Identifiers
- Catalog Number
- 1060 FDA UDI
- Primary DI / UDI-DI
- B12510600 FDA UDI
- 510(k) Number
- K192269 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological diode laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatological diode laser system
TwinScan 808/755 Laser System by GME German Medical Engineering GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- GME German Medical Engineering GmbH
Sources (1)
- FDA UDI 9361b81d-f9fa-4e90-9fbc-c1ccb64477c6 36 fields · synced May 30, 2026