ORICARE L2700— 510(k) K122875

Substantially Equivalent

Oricare, Inc.

FDA 510(k) clearance K122875 for ORICARE L2700, Substantially Equivalent on 2012-12-18. Applicant: Oricare, Inc..

Clearance details

Applicant: Oricare, Inc.
Product code: Code FSY
Advisory panel: General, Plastic Surgery
Date received: 2012-09-19
Decision date: 2012-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quakertow., PA, 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.