Manufacturer
Aesthetic Technology, Ltd.Dermalux Tri-Wave MD
Country / Region:United Kingdom (GB)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K200659
- Device name
- Dermalux Tri-Wave MD
- Company
- Aesthetic Technology, Ltd.
- Country / Region
- United Kingdom(GB)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-03-12
- Decision date
- 2020-05-09
- Submission type
- Traditional
- Technology type
- LED(AI inferred)
- Clinical applications
- Acne treatmentVascular treatmentPigment treatmentOther
- Primary application
- Acne treatment
- Classification source
- AI classified
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 (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.
Intended 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 (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.
Device Description
Dermalux® Tri-Wave MD is a powered laser surgical instrument that utilizes red, blue, and near-infrared light to treat dermatological conditions. It features a power supply of 100-240Vac, 50/60Hz, and operates with three types of light: red light at 633nm±5nm, blue light at 415nm±5nm, and near-infrared light at 830nm±5nm. The device has four panels that can emit the three lights individually or in combination, with specific output power levels for each wavelength.
Summary parsed at:2026-06-01 05:47:54 UTC
Predicate devices
1Phototherapy System
K200659 references 1 predicate/reference device
Cited as predicate
3FlashHeal 2 (FlashHeal 2.0)
EmoLED (v. 2-USA)
Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)
3 submissions cite K200659 as a predicate
