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510(k) K202028

dermalux Flex MD by Aesthetic Technology, Ltd. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2020
Date Received
July 22, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type

Other clearances by Aesthetic Technology, Ltd.

  • K240222 — Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) (June 4, 2024)
  • K212275 — Dermalux Flex MD (November 18, 2021)
  • K200659 — Dermalux Tri-Wave MD (May 9, 2020)

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