Manufacturer
El.En S.P.A.NIRVANA
Country / Region:Italy (IT)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K234057
- Device name
- NIRVANA
- Company
- El.En S.P.A.
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-12-22
- Decision date
- 2024-04-10
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The Nirvana device is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Intended Use
The Nirvana device is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Device 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.
Summary parsed at:2026-06-01 05:27:10 UTC
Predicate devices
2MeDioStar
Deka Luxea
K234057 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K234057 as a predicate