LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES— 510(k) K010834
Substantially EquivalentLaserscope
FDA 510(k) clearance K010834 for LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES, Substantially Equivalent on 2001-05-21. Applicant: Laserscope. Device class: 2.
Clearance details
- Applicant
- Laserscope
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code GEX
view allMore clearances from Laserscope
view all- K062719 — GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
- K061646 — LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
- K034011 — GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
- K024206 — AURA ISURGICAL LASER SYSTEM & ACCESSORIES
- K020021 — LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
Adverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.