HeatLux Pro II— 510(k) K152087

Substantially Equivalent

Home Skinovations , Ltd.

FDA 510(k) clearance K152087 for HeatLux Pro II, Substantially Equivalent on 2016-07-29. Applicant: Home Skinovations , Ltd..

Clearance details

Applicant: Home Skinovations , Ltd.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2015-07-27
Decision date: 2016-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.