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 a medical device manufactured by Home Skinovations , Ltd.. It received FDA 510(k) clearance on 2016-07-29 under approval 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. It is manufactured by Home Skinovations , Ltd.. The 510(k) number is K152087.
When was HeatLux Pro II approved by the FDA?
HeatLux Pro II received FDA 510(k) clearance on 2016-07-29, under approval number K152087.
What company makes HeatLux Pro II?
HeatLux Pro II is manufactured by Home Skinovations , Ltd..
What is the FDA product code for HeatLux Pro II?
The FDA product code for HeatLux Pro II is ILY.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.