(68 days)
The Diode Laser Hair Removal device is intended for 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, Diode Laser Hair Removal device, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
Function module description
a. Control Panel
The module uses the microcontroller as the heart, utilizes the LCD screen to display all prompt information and the system state information to complete the human-machine interaction function, and realizes the device parameters settings and accurate control of the output laser energy by the operator.
b. Main Control Module
The module uses the microcontroller as the heart, receives the laser energy parameters and work instructions from the control panel and detects the footswitch state; Utilizes the sensors of temperature, humidity, liquid level and flow to detect the parameters such as temperature, humidity and water flow during system working, and according to the detected values to calculate the dew point temperature; Controls and detects the work state of constant current board module as well as the temperature and humidity control system; Uploads the state data and alarm information of water circulation system, cooling system, handpiece module and constant current board module during system working.
c. Constant current board module
The module uses the high-power MOS as the heart, receives the laser energy parameters from the main control module, supplies the semiconductor laser with constant drive current which corresponding to the received laser energy parameters to drive the semiconductor laser to emit light. The module also has the detection function of over-current, overvoltage, over-temperature and handpiece state, and uploads the detected data to the control module.
d. Temperature and humidity control system
The system mainly includes the condenser, cold plate, water circulation subsystem and fans. The microcontroller of main control module according to the temperature, humidity parameter detected by the sensors to control the working state of the condenser, cold plate and cooling fan to meet the temperature and humidity requirements during the semiconductor laser working.
e. Handpiece module
Handpiece module is the heart of the device, which is the execution unit of the device and completes the laser emission function. The module is mainly composed of semiconductor laser, sapphire, temperature and humidity sensor, data storage chips, cooling components and water flow path. The semiconductor laser emits light to output energy, temperature and humidity sensors detects the temperature and humidity parameters during handpiece working, the cooling components and water flow path take away the heat of the semiconductor laser to prevent it from being damaged caused by over-temperature, so prolongs the service life of the semiconductor laser.
The provided document is a 510(k) summary for a Diode Laser Hair Removal device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered device. This summary is focused on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than demonstrating the performance of a novel AI/ML-based device.
Specifically, the document states: "No clinical study is included in this submission." This means there is no study described that would involve test sets, ground truth, expert adjudication, or MRMC studies that are typically associated with evaluating AI-powered devices.
However, I can extract the information provided about the device's performance based on non-clinical testing for substantial equivalence:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the sense of predefined thresholds for a novel AI device's performance. Instead, it presents a comparison to a predicate device to demonstrate "substantial equivalence." The "acceptance criteria" here are implicitly that the proposed device performs comparably or within acceptable deviations from the predicate device based on non-clinical tests and safety standards.
| Item | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) | Remark |
|---|---|---|---|
| Product Code | GEX | GEX | SE (Substantially Equivalent) |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Intended Use | Hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction defined as long-term, stable reduction in number of hairs regrowing when measured at 6, 9, and 12 months after a treatment regime. | Hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction defined as long-term, stable reduction in number of hairs regrowing when measured at 6, 9, and 12 months after a treatment regime. | SE |
| Configuration | Main Unit, Handpiece, Foot Control | Main Unit, Handpiece, Foot Control | SE |
| Principle of Operation | Diode Laser | Diode Laser | SE |
| Laser Type | Diode Laser | Diode Laser | SE |
| Laser Classification | Class IV | Class IV | SE |
| Laser Wavelength | 808 nm | 808 nm | SE |
| Spot Size | 1.44 cm2 | 1.44 cm2 | SE |
| Fluence | 1-120 J/cm2 | 1-100 J/cm2 | Discussion (Difference noted, but considered SE based on non-clinical tests) |
| Irradiance | 347.8 W/cm2 | 14-360 W/cm2 | Discussion (Difference noted, but considered SE based on non-clinical tests) |
| Frequency | 0.5-15 Hz | 1-20 Hz | Discussion (Difference noted, but considered SE based on non-clinical tests) |
| Pulse Duration | 5-400 ms | 10-400 ms | Discussion (Difference noted, but considered SE based on non-clinical tests) |
| Power Supply | AC 110V/60Hz | AC 110V-230V/50-60Hz 2000VA | SE |
| Dimension | 450mm× 550mm×380mm | 560mmx380mmx1180mm | Discussion (Difference noted, but considered SE based on non-clinical tests) |
| Weight | 52 Kg | 60 Kg | Discussion (Difference noted, but considered SE based on non-clinical tests) |
| Patient Contact Materials and Biocompatibility | No Cytotoxicity, No evidence of sensitization, No evidence of irritation | No Cytotoxicity, No evidence of sensitization, No evidence of irritation | SE |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | SE |
2. Sample size used for the test set and the data provenance:
Not applicable. The document states "No clinical study is included in this submission." The testing described is non-clinical performance and safety testing directly on the device components or system, not on patient data or clinical samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. See point 2.
4. Adjudication method for the test set:
Not applicable. See point 2.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a laser hair removal system, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. Its performance is evaluated through non-clinical testing against established safety and performance standards relevant to a laser surgical instrument, and by comparison to a predicate device.
7. The type of ground truth used:
For non-clinical tests, the "ground truth" would be the established engineering specifications for the device and compliance with recognized international standards (e.g., IEC standards for electrical, laser, and EMC safety, ISO standards for biocompatibility). For performance aspects like spot size and energy output accuracy, the ground truth is derived from validated measurement techniques.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device. There is no training set mentioned.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML 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.