# K200659: Dermalux Tri-Wave MD

- Pathway: 510(k) (Traditional)
- Applicant: Aesthetic Technology, Ltd.
- Decided: May 9, 2020 after 58 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 11 generations back to K943450 (1995). 93 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190938: Phototherapy System, Shanghai Apolo Medical Technology Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K240222: Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) (2024), 0 descendants of its own
- K240132: EmoLED (v. 2-USA) (2024), 0 descendants of its own
- K233077: FlashHeal 2 (FlashHeal 2.0) (2024), 0 descendants of its own

## Indications for use
The Derrmalux® Tri-Wave MD 's use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The blue light (4l5nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The red light (633nm wavelength) is generally indicated for treatment of superficial, benign, vascular and pigmented lesions. The near-infrared light (830nm wavelength) is generally indicated 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 where applied.

Source page: https://510kreport.com/device/K200659
Methodology: https://510kreport.com/methodology