LPULSA SYL-9000 OPHTHALMIC YAG LASER— 510(k) K990075

Substantially Equivalent

Light-Med(Usa), Inc.

FDA 510(k) clearance K990075 for LPULSA SYL-9000 OPHTHALMIC YAG LASER, Substantially Equivalent on 1999-03-30. Applicant: Light-Med(Usa), Inc..

Clearance details

Applicant: Light-Med(Usa), Inc.
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 1999-01-11
Decision date: 1999-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, 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.