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

Aesthetic Technology, Ltd.

Country / region:United Kingdom (GB)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United Kingdom (GB)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K240222
Device name
Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)
Country / region
United Kingdom(GB)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-01-26
Decision date
2024-06-04
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

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.

Intended 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.

Device Description

The Dermalux Tri-Wave MD MK II & Dermalux Compact MD is a Medical Device (MDR Class IIa, FDA Class II) which emits specific wavelengths of low level, narrow band light for the treatment of certain aesthetic, dermatological and medical indications. The wavelengths used in the Tri-Wave MD MK II & Compact MD systems are Blue 415nm, Red 633nm and Near Infrared 830nm. The Dermalux professional use family consists of the Tri-Wave MD MKII; a floor standing unit with 4 pod treatment head, Compact MD; desk mounted unit with a 3 pod treatment head. The system enables treatment of the face and the body via an articulated 4 or 3 panel LED head. The panels can be easily adjusted for focused intensity treatments and application to larger body areas. The system consists of a main body that contains the power supply (100-240Vac, 50/60Hz), power switch, touch screen control panel and a 4 or 3 panel adjustable treatment head that contains Light Emitting Diodes (LEDs). The power supply is designed to power the internal electronics for the system and the Light Emitting Diodes. The power supply is connected to a suitable mains outlet. The device is switched ON/OFF by a switch located below the screen in the base unit. The Tri-Wave MD MK II & Compact MD system is operated by a full colour capacitive touch screen which features pre-set and post treatment protocols that can be customised with three power settings. Bespoke protocols can be programmed based on delivered energy or time. The device cannot be networked or connect to the internet, software updates can be performed via a USB flash drive (thumb drive) if required. The light is generated by Light Emitting Diodes (LED's) which are contained within a treatment head. The treatment head is connected to the main body by articulating arm mechanism. The arm allows the operator to correctly position the LED head over the treatment area. Protective eye wear is supplied with each Dermalux unit for patient and operator comfort.

Summary parsed at:2026-06-01 05:27:27 UTC

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