# K202028: dermalux Flex MD

- Pathway: 510(k) (Traditional)
- Applicant: Aesthetic Technology, Ltd.
- Decided: Dec 16, 2020 after 147 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K943450 (1995). 146 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152280: BioPhotas Celluma3, Biophotas, Inc. (2016) Summary page 4.
- K171323: Biophotas CELLUMA3, Biophotas, Inc. (2017) Summary page 4.
- K133896: Rejuvalite MD, Trophy Skin, Inc. (2014) Summary page 4.
- K201107: Opera Lebody (Gold), Opera Lebody (Zafiro), Gtg Wellness Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K212275: Dermalux Flex MD (2021), 4 descendants of its own
- 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/K202028
Methodology: https://510kreport.com/methodology