PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar— 510(k) K180402
Substantially EquivalentTopcon Medical Laser Systems, Inc.
FDA 510(k) clearance K180402 for PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar, Substantially Equivalent on 2018-05-25. Applicant: Topcon Medical Laser Systems, Inc..
Clearance details
- Applicant
- Topcon Medical Laser Systems, Inc.
- Product code
- Code HQF
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Livermore, CA, US
Adverse events under product code HQF
product code HQF- Injury
- 166
- Other
- 1
- Total
- 167
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.