# K234057: Nirvana

- Pathway: 510(k) (Traditional)
- Applicant: El.En S.P.A.
- Decided: Apr 10, 2024 after 110 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K943450 (1995). 554 ancestors in all.
No later device cites it as a predicate yet.
0 of 555 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192539: Deka Luxea, El.En Electronic Engineering Spa (2019) Summary page 5.
- K192483: MeDioStar, Asclepion Laser Technologies GmbH (2020) Summary page 5.

## 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.

Source page: https://510kreport.com/device/K234057
Methodology: https://510kreport.com/methodology