Identity
- Trade Name
- Empower H65 FDA UDI
- Generic Name
- General/multiple surgical solid-state laser system FDA UDI
- Device Name
- Distributed by Gyrus ACMI, L.P. FDA UDI
- Model / Reference
- EMP-H65 FDA UDI
- Description
- Distributed by Gyrus ACMI, L.P. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033945938901 FDA UDI
- 510(k) Number
- K180423 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
Empower H65 by Quanta System Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K180423 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
- Quanta System Spa
Sources (1)
- FDA UDI b7c1a019-532f-4566-9ae0-6aaadbcd94d4 35 fields · synced Jun 8, 2026