# K964818: Orion Series Surgical Laser System (Q-Switched ND:Yag Configuration)

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Jun 17, 1997 after 200 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medlite™ Q-switched Nd:YAG Laser System: named in the summary without a submission number

## Indications for use
The Orion Series Surgical Laser System (Q-switched Nd:YAG configuration) is intended for removal of dark tattoo ink, including blue and black

Source page: https://510kreport.com/device/K964818
Methodology: https://510kreport.com/methodology