LION Photocoagulator— 510(k) K201623

Substantially Equivalent

Norlase Aps

FDA 510(k) clearance K201623 for LION Photocoagulator, Substantially Equivalent on 2020-08-11. Applicant: Norlase Aps.

Clearance details

Applicant: Norlase Aps
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2020-06-15
Decision date: 2020-08-11
Decision: Substantially Equivalent
Clearance type: Special
Location: 2750 Ballerup, DK

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.