# K170970: Epilaser

- Pathway: 510(k) (Traditional)
- Applicant: Epilady 2000, LLC
- Decided: Sep 1, 2017 after 154 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: 12 generations back to K950019 (1995). 29 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090820: Tria Hair Removal Laser System, Spectragenics, Inc. (2009) Summary page 4.
- K120737: Tria Laser Hair Removal System, Tria Beauty, Inc. (2012) Summary page 4.

## Most influential descendants
- K213105: Epilaser Absolute (2022), 1 descendant of its own
- K233224: Epilaser Pro (2024), 0 descendants of its own

## Indications for use
Epilaser 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 hair counts following a treatment regime. Permanent hair reduction is defined as 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/K170970
Methodology: https://510kreport.com/methodology