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FDA 510(k)

HeatLux Pro II

K-Number: K152087 · 2016-07-29

ApplicantHome Skinovations , Ltd.
Decision Date2016-07-29
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HeatLux Pro II is the device name listed in this FDA 510(k) record. The listed applicant is Home Skinovations , Ltd.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K152087. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HeatLux Pro II?

HeatLux Pro II is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Home Skinovations , Ltd.. The 510(k) number is K152087.

When did HeatLux Pro II receive FDA 510(k) clearance?

HeatLux Pro II received FDA 510(k) clearance on 2016-07-29, under 510(k) number K152087.

Who is the listed applicant for HeatLux Pro II?

The FDA 510(k) record lists Home Skinovations , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HeatLux Pro II?

The FDA product code for HeatLux Pro II is ILY.

Other records listing Home Skinovations , Ltd. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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