# K990718: Orion Series Surgical  Laser System (SL Seriesq-Switched ND:Yag Configuration)

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Mar 8, 2000 after 370 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
No predicates in its family tree.
745 later devices descend from it; 6 cite it directly.
0 of 746 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K014040: Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models (2002), 739 descendants of its own
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own
- K022923: Candela Gentle Yag Laser System (2003), 656 descendants of its own
- K023193: Candela Gentle Yag Laser System (2002), 656 descendants of its own
- K033172: Candela Gentleyag Family of Laser Systems (2003), 654 descendants of its own

## Indications for use
The Orion Series Surgical Laser System and the Lyra Surgical Laser System are intended for the lightening and removal of unwanted body hair in Fitzpatrick Skin Ty

Source page: https://510kreport.com/device/K990718
Methodology: https://510kreport.com/methodology