# K010284: Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration)

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: May 1, 2001 after 90 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
357 later devices descend from it; 5 cite it directly.
0 of 358 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
- K071295: 100W Ceralas D 980NM Diode Laser (2007), 230 descendants of its own
- K072106: 150W Ceralas D 980NM Diode Laser (2007), 229 descendants of its own
- K023881: Profile 1064 Laser System (2003), 227 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own

## Recalls of this device
- Feb 8, 2010 · Not classified · Z-1229-2011: A failure mode whereby the fiber attachment to the GreenLight PV laser system could inadvertently be broken. If fiber were to bend sharply at point of fiber connection, it may break and cause a burn.
- Jun 18, 2007 · Not classified · Z-0131-2008: Control knob break: The knob used to finely control the direction of the laser energy may break.
- Apr 17, 2007 · Not classified · Z-0130-2008: Component missing: Some products were issued without thermal protection switches.

Source page: https://510kreport.com/device/K010284
Methodology: https://510kreport.com/methodology