800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES— 510(k) K972575
Substantially EquivalentLaserscope
FDA 510(k) clearance K972575 for 800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES, Substantially Equivalent on 1998-07-17. 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.