Identity
- Trade Name
- NIRVANA FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Device Name
- The NIRVANA is a diode laser device indicated for hair removal and permanent hair reduction. The device is provided with two different handpieces that deliver the laser energy to the patient. The NIRVANA electrical specifications are: 100-115V~, 50/60Hz, 1600VA. FDA UDI
- Model / Reference
- M117H1 FDA UDI
- Description
- The NIRVANA is a diode laser device indicated for hair removal and permanent hair reduction. The device is provided with two different handpieces that deliver the laser energy to the patient. The NIRVANA electrical specifications are: 100-115V~, 50/60Hz, 1600VA. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057017760856 FDA UDI
- 510(k) Number
- K234057 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological 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: Dermatological diode laser system
Nirvana by El.en. Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- El.en. Spa
Sources (1)
- FDA UDI c6f80885-a842-4b7a-b544-fb87d3c0bd7e 35 fields · synced Jun 9, 2026