SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC— 510(k) K854998
Substantially EquivalentDirected Energy, Inc.
FDA 510(k) clearance K854998 for SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC, Substantially Equivalent on 1986-05-02. Applicant: Directed Energy, Inc.. Device class: 2.
Clearance details
- Applicant
- Directed Energy, Inc.
- 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
- Los Angeles, CA, US
Recent devices under product code GEX
view allMore clearances from Directed Energy, Inc.
view allAdverse 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.