PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System— 510(k) K170409
Substantially EquivalentTopcon Medical Laser Systems, Inc. (Tmls)
FDA 510(k) clearance K170409 for PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System, Substantially Equivalent on 2017-09-12. Applicant: Topcon Medical Laser Systems, Inc. (Tmls). Device class: 2.
Clearance details
- Applicant
- Topcon Medical Laser Systems, Inc. (Tmls)
- 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
- Livermore, CA, US
Recent devices under product code GEX
view allMore clearances from Topcon Medical Laser Systems, Inc. (Tmls)
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.