LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR— 510(k) K021538

Substantially Equivalent

Lightmed Corp.

FDA 510(k) clearance K021538 for LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR, Substantially Equivalent on 2002-08-08. Applicant: Lightmed Corp..

Clearance details

Applicant: Lightmed Corp.
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2002-05-10
Decision date: 2002-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shulin City, TW

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.