FDA 510(k)

dermalux Flex MD

K-Number: K202028 · 2020-12-16

Decision Date2020-12-16

Product CodeILY

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

dermalux Flex MD is a medical device manufactured by Aesthetic Technology, Ltd.. It received FDA 510(k) clearance on 2020-12-16 under approval number K202028. 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 dermalux Flex MD?

dermalux Flex MD is a medical device that received FDA 510(k) clearance on 2020-12-16. It is manufactured by Aesthetic Technology, Ltd.. The 510(k) number is K202028.

When was dermalux Flex MD approved by the FDA?

dermalux Flex MD received FDA 510(k) clearance on 2020-12-16, under approval number K202028.

What company makes dermalux Flex MD?

dermalux Flex MD is manufactured by Aesthetic Technology, Ltd..

What is the FDA product code for dermalux Flex MD?

The FDA product code for dermalux Flex MD is ILY.

Other Devices by Aesthetic Technology, Ltd.

K200659Dermalux Tri-Wave MD K212275Dermalux Flex MD K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)

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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.