SILKN BLUE— 510(k) K121435

Substantially Equivalent

Home Skinovations , Ltd.

FDA 510(k) clearance K121435 for SILKN BLUE, Substantially Equivalent on 2013-02-22. Applicant: Home Skinovations , Ltd..

Clearance details

Applicant: Home Skinovations , Ltd.
Product code: Code OLP
Advisory panel: General, Plastic Surgery
Date received: 2012-05-14
Decision date: 2013-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam Illit, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLP

product code OLP

Other: 1
Total: 1

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.