DeviceClearance

LC-250 INFRARED LIGHT COAGULATOR— 510(k) K964380

Substantially Equivalent

Nk-Optik America

FDA 510(k) clearance K964380 for LC-250 INFRARED LIGHT COAGULATOR, Substantially Equivalent on 1997-01-22. Applicant: Nk-Optik America.

Clearance details

Applicant
Nk-Optik America
Product code
Code HQB
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chicago, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HQB

product code HQB
Other
2
Total
2

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.