AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM— 510(k) K961710
Substantially EquivalentApplied Optronics Corp.
FDA 510(k) clearance K961710 for AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM, Substantially Equivalent on 1996-11-01. Applicant: Applied Optronics Corp.. Device class: 2.
Clearance details
- Applicant
- Applied Optronics Corp.
- 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
- South Plainfield, NJ, US
Recent devices under product code GEX
view allMore clearances from Applied Optronics Corp.
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.