ALM PRISMALIX (PRX) SURGICAL LIGHT— 510(k) K982063

Substantially Equivalent

Alm Surgical Equipment, Inc.

FDA 510(k) clearance K982063 for ALM PRISMALIX (PRX) SURGICAL LIGHT, Substantially Equivalent on 1998-09-22. Applicant: Alm Surgical Equipment, Inc..

Clearance details

Applicant: Alm Surgical Equipment, Inc.
Product code: Code FSY
Advisory panel: General, Plastic Surgery
Date received: 1998-06-12
Decision date: 1998-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

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.