# K233224: Epilaser Pro

- Pathway: 510(k) (Traditional)
- Applicant: Epilady 2000, LLC
- Decided: Jan 27, 2024 after 121 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: 18 generations back to K943450 (1995). 245 ancestors in all.
No later device cites it as a predicate yet.
0 of 246 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170970: Epilaser, Epilady 2000, LLC (2017) Summary page 5.
- K213105: Epilaser Absolute, Epilady 2000, LLC (2022) Summary page 5.

## Indications for use
Epilaser Pro is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth (defined as a long-term, stable reduction in the number of hairs regrowing) when measured out to 6, 9, and 12 months after the completion of the treatment regimen.

Source page: https://510kreport.com/device/K233224
Methodology: https://510kreport.com/methodology