# Laserscope

- Location (FDA's records): San Jose, CA
- FDA decisions: 60 (1985–2006): 60 510(k) clearances
- Product codes: GEX (49), LNK (3), EWG (2), HHR (2), GEI (1), FBO (1), LMS (1), GCJ (1)
- Predicates its devices cite: 7 (4 its own); citations of its devices by later devices: 113 (4 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Heraeus Surgical, Inc.: 1 (https://510kreport.com/company/heraeus-surgical)
- Cooltouch Corp.: 1 (https://510kreport.com/company/cooltouch)
- Sls Biophile, Ltd.: 1 (https://510kreport.com/company/sls-biophile)

## Firms that cite its devices most
- Adept Medical Concepts: 18 (https://510kreport.com/company/adept-medical-concepts)
- Candela Corp.: 9 (https://510kreport.com/company/candela)
- Altus Medical, Inc.: 7 (https://510kreport.com/company/altus-medical)
- Depilase Group, Ltd.: 7 (https://510kreport.com/company/depilase-group)
- Sciton, Inc: 7 (https://510kreport.com/company/sciton)
- Fotona D.D.: 5 (https://510kreport.com/company/fotona-dd)
- Quantel Medical: 5 (https://510kreport.com/company/quantel-medical)
- Wavelight Laser Technologie AG: 4 (https://510kreport.com/company/wavelight-laser-technologie)

## Its most-cited devices
- K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration) (2002), cited by 15
- K990903: Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration) (1999), cited by 13
- K003147: Lyra Series Surgical Laser System (SL Series, ND:Yag Configuration) (2000), cited by 8
- K951034: Aura Laser System (1995), cited by 8
- K010834: Lyra Series Surgical Laser System & Accessories (2001), cited by 8
- K003765: Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration) (2001), cited by 7

## Recent decisions
- K062719: Greenlight HPS Series Surgical Laser System & Accessories (Dec 1, 2006)
- K061646: Laserscope Guided Delivery Device (GDD) Cystourethroscope & Accessories (Jun 27, 2006)
- K034011: Gemini Surgical Laser System & Accessories (Mar 30, 2004)
- K024206: Aura Isurgical Laser System & Accessories (Nov 17, 2003)
- K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration) (Jul 2, 2002)
- K010834: Lyra Series Surgical Laser System & Accessories (May 21, 2001)
- K010284: Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration) (May 1, 2001)
- K003765: Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration) (Mar 6, 2001)

Source page: https://510kreport.com/company/laserscope