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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 the device name listed in this FDA 510(k) record. The listed applicant is Aesthetic Technology, Ltd.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) 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. The listed applicant is Aesthetic Technology, Ltd.. The 510(k) number is K212275.

When did Dermalux Flex MD receive FDA 510(k) clearance?

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

Who is the listed applicant for Dermalux Flex MD?

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

What is the FDA product code for Dermalux Flex MD?

The FDA product code for Dermalux Flex MD is OHS.

Other records listing Aesthetic Technology, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)K202028dermalux Flex MDK200659Dermalux Tri-Wave MD

Related Devices (Code: OHS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading LimitedK261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLCK2605985 Wavelength LED Facemask (TN2508)iSMART Developments, Ltd.

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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