# K213105: Epilaser Absolute

- Pathway: 510(k) (Traditional)
- Applicant: Epilady 2000, LLC
- Decided: Dec 13, 2022 after 445 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: 17 generations back to K943450 (1995). 244 ancestors in all.
1 later device descends from it; 1 cites it directly.
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). Our reading of the summary gave K170790, FDA’s number for SAM CRRT Unit, SAM Cassette CRRT (Spectral Medical, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Epilaser”.
- K141063: Linscan 808, Linscan 980, Gme (German Medical Engineering) GmbH (2014) Summary page 4.

## Most influential descendants
- K233224: Epilaser Pro (2024), 0 descendants of its own

## Indications for use
Epilaser Absolute 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/K213105
Methodology: https://510kreport.com/methodology