Identity
- Trade Name
- MH01 FDA UDI
- Generic Name
- General/multiple surgical solid-state laser system FDA UDI
- Device Name
- Holmium medical laser system FDA UDI
- Model / Reference
- PVMS00044 FDA UDI
- Description
- Holmium medical laser system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033945935863 FDA UDI
- 510(k) Number
- K152220 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
- Not 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
Mh01 by Quanta System Spa — Class II — FDA_510K, MDD — listed in FDA GUDID, FDA 510(k), EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Unknown
MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152220 | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Unknown |
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Manufacturer
- Manufacturer
- Quanta System Spa
Sources (3)
- FDA UDI 1db2d2cd-ada7-4d50-b829-417d1e5dd6f4 59 fields · synced Jun 18, 2026
- FDA 510(k) K152220 1 fields · synced Jun 4, 2026
- EUDAMED 1 fields · synced Jun 3, 2026