# K121162: Polaris Q-Switch Ruby System

- Pathway: 510(k) (Traditional)
- Applicant: Sandstone Medical Technologies, LLC
- Decided: Jul 18, 2012 after 92 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: 3 generations back to K950019 (1995). 5 ancestors in all.
38 later devices descend from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971193: Laseaway Long Pulse and Q-Switched Ruby Laser System, Polytec Pi, Inc. (1997)

## Most influential descendants
- K152012: EVO platform (2015), 37 descendants of its own
- K160368: EVO platform (2016), 36 descendants of its own
- K163222: Discovery Pico Family (2016), 30 descendants of its own
- K171945: Discovery Pico, Discovery Pico Plus (2017), 21 descendants of its own
- K172376: Discovery Pico, Discovery Pico Plus (2017), 20 descendants of its own

## Indications for use
The Polaris Long Pulse and 0-Switched Ruby Laser is intended to remove blueiblack tattoos and benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery

Source page: https://510kreport.com/device/K121162
Methodology: https://510kreport.com/methodology