510(k) Report

Devices descending from K200659

3 later devices reach Dermalux Tri-Wave MD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Aesthetic Technology, Ltd.20240—
+1K240132EmoLED (v. 2-USA)Emoled, Srl20240—
+1K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—