# K240222: Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)

- Pathway: 510(k) (Traditional)
- Applicant: Aesthetic Technology, Ltd.
- Decided: Jun 4, 2024 after 130 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: 12 generations back to K943450 (1995). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200659: Dermalux Tri-Wave MD, Aesthetic Technology, Ltd. (2020) Summary page 5.

## Indications for use
Indications for use include: • The blue light (415nm 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/K240222
Methodology: https://510kreport.com/methodology