# K212275: Dermalux Flex MD

- Pathway: 510(k) (Traditional)
- Applicant: Aesthetic Technology, Ltd.
- Decided: Nov 18, 2021 after 121 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K943450 (1995). 148 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202028: dermalux Flex MD, Aesthetic Technology, Ltd. (2020) Summary page 4.
- K200983: Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine, Ningbo Hesi Electric Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K251012: TRUDERMAL Pro (ZLD-390) (2025), 1 descendant of its own
- K260945: Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2) (2026), 0 descendants of its own
- K260946: LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) (2026), 0 descendants of its own
- K253874: LED Therapy Light (COB1400, HP1800PRO) (2026), 0 descendants of its own

## Indications for use
Intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris. Intended to emit energy in the red and infrared spectrum for the use in dermatology for the treatment of periorbital and full face wrinkles.

Source page: https://510kreport.com/device/K212275
Methodology: https://510kreport.com/methodology