Identity
- Trade Name
- QuardoStar PRO FDA UDI
- Generic Name
- General/multiple surgical diode laser system FDA UDI
- Device Name
- Dermatological laser with 577 nm. Intended for the treatment of benign vascular and pigmented lesions. (prepared for scanner adaption) FDA UDI
- Model / Reference
- 1493 FDA UDI
- Description
- Dermatological laser with 577 nm. Intended for the treatment of benign vascular and pigmented lesions. (prepared for scanner adaption) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04058784000057 FDA UDI
- 510(k) Number
- K133297 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical 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: General/multiple surgical diode laser system
QuardoStar PRO by Asclepion Laser Technologies GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K133297 also covers:
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
- Asclepion Laser Technologies GmbH
Sources (1)
- FDA UDI 67c86f39-6c63-43ae-8c13-b249c24c3917 35 fields · synced May 30, 2026