MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM— 510(k) K854387
Substantially EquivalentDirected Energy, Inc.
FDA 510(k) clearance K854387 for MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM, Substantially Equivalent on 1986-02-07. 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.