dermalux Flex MD

Q: When was dermalux Flex MD cleared by the FDA?

dermalux Flex MD (K202028) received a 510(k) decision of Substantially Equivalent on December 16, 2020, 147 days after the submission was received.

Q: What is the product code of K202028?

The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.

FDA 510(k) K202028 · Aesthetic Technology, Ltd.

Substantially Equivalent

510(k) numberK202028

Submission

Device name: dermalux Flex MD
Applicant: Aesthetic Technology, Ltd.
Warrington, GB
Received: July 22, 2020
Decision date: December 16, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: ILY – Lamp, Infrared, Therapeutic Heating
Device class: Class II (moderate risk)
Regulation: 21 CFR 890.5500
Specialty: Physical Medicine

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More from Chogqing Yuhe Medical Instruments Co., Ltd.

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Questions and answers

When was dermalux Flex MD cleared by the FDA?

dermalux Flex MD (K202028) received a 510(k) decision of Substantially Equivalent on December 16, 2020, 147 days after the submission was received.

What is the product code of K202028?

The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.