HEATLUX— 510(k) K120582

Substantially Equivalent

Home Skinovations , Ltd.

FDA 510(k) clearance K120582 for HEATLUX, Substantially Equivalent on 2012-07-06. Applicant: Home Skinovations , Ltd..

Clearance details

Applicant: Home Skinovations , Ltd.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2012-02-27
Decision date: 2012-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam Illit, IL

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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.