Identity
- Trade Name
- TattooStar R FDA UDI
- Generic Name
- Dermatological frequency-doubled solid-state laser system FDA UDI
- Model / Reference
- 1640 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04058784000125 FDA UDI
- 510(k) Number
- K060787 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological frequency-doubled solid-state 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 frequency-doubled solid-state laser system
TattooStar R by Asclepion Laser Technologies GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological frequency-doubled solid-state laser system.
- QuRAS Collimation H/P — ILOODA.CO., LTD · Class II
- PicoLO User Manual — Laseroptek Co., Ltd · Class II
- LIGHT B — Quanta System Spa · Class II
- Domino — Quanta System Spa · Class II
- Discovery Pico — Quanta System Spa · Class II
- Asset — Quanta System Spa · Class II
- ALEX TriVantage — Candela Corporation · Class II
- CuRAS Main Unit — CLASSYS Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Asclepion Laser Technologies GmbH
Sources (1)
- FDA UDI 4b963f7b-fade-4f74-98b0-01b6c0604ec8 33 fields · synced May 30, 2026