# K222369: PURE Laser

- Pathway: 510(k) (Traditional)
- Applicant: Endymed Medical, Ltd.
- Decided: Oct 7, 2022 after 63 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: 24 generations back to K943450 (1995). 528 ancestors in all.
No later device cites it as a predicate yet.
0 of 529 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193367: elysion-pro, High Technology Products S.L.U (2020) Summary page 4.

## Indications for use
Indications for use for the Pure Laser diode hair removal system with a 810nm applicator include: * Hair removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. * Treatment of Pseudo folliculitis Barbae (PFB) * Use on all skin types (Fitzpatrick 1-VI)

Source page: https://510kreport.com/device/K222369
Methodology: https://510kreport.com/methodology