# K010834: Lyra Series Surgical Laser System & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: May 21, 2001 after 62 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.
728 later devices descend from it; 8 cite it directly.
0 of 729 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033172: Candela Gentleyag Family of Laser Systems (2003), 654 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K040617: Reliant Laser System II (2004), 316 descendants of its own
- K042319: Reliant Laser II System and Accessories (2005), 284 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own

Source page: https://510kreport.com/device/K010834
Methodology: https://510kreport.com/methodology