# K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Jul 2, 2002 after 180 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: 1 generation back to K000811 (2000). 2 ancestors in all.
740 later devices descend from it; 15 cite it directly.
0 of 743 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003715: Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model Cooltouch, Cooltouch II, Cooltouch Corp. (2001) Summary page 2.
- K000811: Nlite System, SLS Model Number A00-1025, Sls Biophile, Ltd. (2000)

## Cited in the summary but kept off the family tree
- K9990903: Lyra Surgical Laser System. Number could not be read Summary page 2.

## Most influential descendants
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own
- K022951: Candela Gentle Yag Laser System, Variable Pulse Yag (2003), 657 descendants of its own
- K033172: Candela Gentleyag Family of Laser Systems (2003), 654 descendants of its own
- K033251: The Friendlylight ND: Yag Lasers (2004), 519 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own

## Indications for use
The Laserscope LyraTMLaser Systems & Accessories are indicated for use in the Dermatological applications for the treatment of facial wrinkles.

Source page: https://510kreport.com/device/K020021
Methodology: https://510kreport.com/methodology