Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Dermalux Flex MD

K-Number: K212275 · 2021-11-18

ApplicantAesthetic Technology, Ltd.
Decision Date2021-11-18
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dermalux Flex MD is a medical device manufactured by Aesthetic Technology, Ltd.. It received FDA 510(k) clearance on 2021-11-18 under approval number K212275. The device is classified under product code OHS. It was reviewed by the SU 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 2021-11-18. It is manufactured by Aesthetic Technology, Ltd.. The 510(k) number is K212275.

When was Dermalux Flex MD approved by the FDA?

Dermalux Flex MD received FDA 510(k) clearance on 2021-11-18, under approval number K212275.

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 OHS.

Other Devices by Aesthetic Technology, Ltd.

K202028dermalux Flex MD K200659Dermalux Tri-Wave MD K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)

Related Devices (Code: OHS)

K161849BrightTanda Beauty Canada, Inc. K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity K151337StrialiteCentre Light Solutions, LLC K171323BIOPHOTAS CELLUMA3Biophotas, Inc. K170984LG BEAUTY LED MASKLg Electronics K171386dpl SpectraLiteLed Technologies, Inc.

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.

↑