# K153718: Spirit Hair Removal laser Family

- Pathway: 510(k) (Traditional)
- Applicant: Active Optical Systems, Ltd.
- Decided: Feb 12, 2016 after 46 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: 11 generations back to K910422 (1992). 59 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112031: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family of Soprano XL Multi-Application, Alma Lasers, Inc. (2011) Summary page 4.

## Most influential descendants
- K181019: Diode Laser System (2018), 6 descendants of its own
- K200525: Medical Diode Laser Hair Removal System (2020), 1 descendant of its own
- K192569: Diode Laser Therapy System (2019), 1 descendant of its own
- K192516: Diode Laser 808nm (2019), 1 descendant of its own
- K241860: Diode Laser Hair Removal System (2024), 0 descendants of its own

## Indications for use
The Spirit Hair Removal laser Family is generally intended for dermatological use. The devices are specifically indicated for hair removal, permanent hair reduction by using selective laser energy. The Spirit Hair Removal laser Family is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent reduction in hair regrowth is defined as the longterm, 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/K153718
Methodology: https://510kreport.com/methodology