(130 days)
Indications for use include:
· The blue light (415nm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
· The red light (633nm wavelength) 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.
The Dermalux Tri-Wave MD MK II & Dermalux Compact MD is a Medical Device (MDR 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 MKI; 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 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 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 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 ment area.
Protective eye wear is supplied with each Dermalux unit for patient and operator comfort.
The Dermalux systems are not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent.
The provided text is a 510(k) summary for the Dermalux Tri-Wave MD MKII and Dermalux Compact MD devices. It details the device descriptions, intended use, and a comparison to a predicate device (Dermalux Tri-Wave MD, K200659).
However, this document does not contain information about acceptance criteria for device performance, nor details of specific studies that prove the device meets such criteria. It's a regulatory submission affirming substantial equivalence to a predicate device, based on similar technology and indications for use. It states that "The conclusions drawn from the noncinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section," but it does not provide the details of those non-clinical tests, their results, or any acceptance criteria.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and performance studies, including sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.
The document mainly focuses on:
- Device Identification: Dermalux Tri-Wave MD MKII (1000021) and Dermalux Compact MD (1000024).
- Intended Use/Indications for Use:
- Blue light (415nm): Treat moderate inflammatory acne vulgaris.
- Red light (633nm): Treatment of superficial, benign, vascular and pigmented lesions.
- Near-infrared light (830nm): Temporary relief of minor muscle and joint pain, arthritis, muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; temporarily increasing local blood circulation.
- Predicate Device: Dermalux Tri-Wave MD (K200659).
- Technological Comparison: States that the new devices have "the same technological characteristicans for use" as the predicate device.
The document does not describe any specific performance study, acceptance criteria, or statistical measures related to efficacy or performance for this specific submission. It relies on substantial equivalence to the predicate device.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.