(88 days)
The Diode Laser 808nm is intended for hair removal, permanent hair reduction on all skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Diode Laser 808nm is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The proposed device has six main function modules as following:
Water cooling system:
Through refrigeration compressor to achieve heat and cold exchange of air, the internal water tank by the water and water pump for cooling water cycle, with cooling water to cool the parts of the tools, the system to achieve this function is called water cooling system.
Power system:
Through the main circuit control system, according to the control requirements to provide the size of laser energy, the system to achieve this function is called the power system.
User Interface system:
Through the display screen and touch screen, 1. Provide users with relevant information about display equipment; 2. Users operate or set relevant parameters or functions; 3. Display fault information. The system that realizes this function is called human-machine switching system.
Handpiece system:
According to the choice of different treatment methods to choose the appropriate treatment tools, the system to achieve this function is called the handpiece system.
Main circuit power supply system:
The system that realizes the power supply of equipment and the control switch or stops the power supply is called the main circuit power supply system.
Main circuit control system:
It is used to control the parts of the equipment to work in a reasonable sequence and provide fault or warning sound. The system that realizes this function is called the main circuit control system.
The provided document is a 510(k) Premarket Notification from the U.S. FDA for a Diode Laser 808nm, Model: SL-HR10. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through detailed acceptance criteria and human studies for AI/software devices.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and studies for an AI/software device. Specifically, it does not include:
- A table of acceptance criteria and reported device performance for an AI/software system.
- Sample sizes for test sets, data provenance, or details on ground truth establishment for AI/software.
- Information on experts used to establish ground truth or adjudication methods for AI/software.
- Details about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Sample sizes or ground truth establishment methods for training sets of an AI/software.
Instead, the document details:
- Device Name: Diode Laser 808nm, Model: SL-HR10
- Intended Use: Hair removal, permanent hair reduction on all skin types (I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in hair regrowth measured at 6, 9, and 12 months post-treatment.
- Basis for SE: Non-clinical tests verifying compliance with relevant medical device safety and performance standards (e.g., AAMI/ANSI/ES 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10).
- Comparison to Predicates: The device is compared to two predicate devices (K180353 and K181019) on product code, regulation number, intended use, configuration, principle of operation, laser type, classification, wavelength, spot size, fluence, frequency, pulse duration, power supply, dimension, weight, patient contact materials, and biocompatibility.
- No Clinical Study: The document explicitly states: "No clinical study is included in this submission."
In summary, this FDA submission is for a laser device, and its approval is based on demonstrating substantial equivalence to existing devices through non-clinical testing against established safety and performance standards, not through clinical trials or AI/software specific performance metrics.
§ 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.