# K971193: Laseaway Long Pulse and Q-Switched Ruby Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Polytec Pi, Inc.
- Decided: Jun 24, 1997 after 84 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: 2 generations back to K950019 (1995). 4 ancestors in all.
39 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)
- K942343: Laseaway Q-Switched Ruby Laser System, Polytec Pi, Inc. (1994) Summary page 1.
- K963947: Epilaser Normal Mode Ruby Laser, Spectrum Medical Technologies, Inc. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K962996: EpiTouch™ Ruby Laser System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K121162: Polaris Q-Switch Ruby System (2012), 38 descendants of its own
- 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

## Indications for use
The LaseAway Long Pulse and Q-Switched Ruby Laser System is intended to remove blue/black 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/K971193
Methodology: https://510kreport.com/methodology