Identity
- Trade Name
- Litho FDA UDI
- Generic Name
- General/multiple surgical solid-state laser system FDA UDI
- Device Name
- 35W, 5J. FDA UDI
- Model / Reference
- PVMS00046 FDA UDI
- Description
- 35W, 5J. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033945936785 FDA UDI
- 510(k) Number
- K163009 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical 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: General/multiple surgical solid-state laser system
Litho by Quanta System Spa — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Also classified as General/multiple surgical solid-state laser system.
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- Thuvera — IPG Medical Corporation · Class II
- ACCENTO — Bison Medical Co, Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163009 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K141101 | Class II | Active |
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Manufacturer
- Manufacturer
- Quanta System Spa
Sources (2)
- FDA UDI a2fe3887-4c7c-438b-a82b-a0b754518a22 58 fields · synced Jun 18, 2026
- FDA 510(k) K163009 1 fields · synced Jun 5, 2026