PASCAL LASER INDIRECT OPHTHALMOSCOPE— 510(k) K123056

Substantially Equivalent

Topcon Medical Laser Systems, Inc. (Tmls)

FDA 510(k) clearance K123056 for PASCAL LASER INDIRECT OPHTHALMOSCOPE, Substantially Equivalent on 2012-11-13. Applicant: Topcon Medical Laser Systems, Inc. (Tmls).

Clearance details

Applicant: Topcon Medical Laser Systems, Inc. (Tmls)
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2012-10-01
Decision date: 2012-11-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasant Hill, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.