(263 days)
The Diode Laser System 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 System, 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.
This document is a 510(k) premarket notification for a medical device, specifically a Diode Laser Hair Removal System. It does not describe a study involving acceptance criteria for diagnostic performance outcomes (like sensitivity, specificity, accuracy) but rather focuses on verifying that the proposed device meets design specifications and is substantially equivalent to a predicate device.
Therefore, many of the requested categories (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of submission. This document details engineering and safety compliance rather than a clinical performance study.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in terms of clinical performance metrics for diagnosis (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are implied by compliance with various international standards for medical electrical equipment, laser safety, and biocompatibility, as well as comparison to a predicate device's technical specifications. The "reported device performance" is essentially that the device complies with these standards and its technical specifications are comparable to the predicate.
| Acceptance Criterion (Implied) | Reported Device Compliance/Performance |
|---|---|
| Safety and Performance Standards | |
| IEC 60601-1:2012 | Complies (Medical Electrical Equipment - General Requirements For Basic Safety And Essential Performance) |
| IEC 60601-2-22:2007 | Complies (Medical Electrical Equipment - Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment) |
| IEC 60825-1:2007 | Complies (Safety of laser products - Equipment classification and requirements) |
| IEC 60601-1-2:2007 | Complies (Medical electrical equipment- Electromagnetic compatibility) |
| Biocompatibility | |
| ISO 10993-5:2009 (Cytotoxicity) | No Cytotoxicity |
| ISO 10993-10:2002/Amd. 1:2006 (Sensitization) | No evidence of sensitization |
| ISO 10993-10:2002/Amd. 1:2006 (Irritation) | No evidence of irritation |
| Technical Specifications (Comparison to Predicate) | |
| Product Code | GEX (Substantially Equivalent - SE) |
| Regulation Number | 21 CFR 878.4810 (SE) |
| Intended Use | Hair removal, permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair number at 6, 9, and 12 months post-treatment. (SE to predicate K141973, comparable to K123483) |
| Configuration | Main Unit, Handpiece, Foot Control (SE) |
| Principle of Operation | Diode Laser (SE) |
| Laser Type | Diode Laser (SE) |
| Laser Classification | Class IV (SE) |
| Laser Wavelength | 808 nm (SE) |
| Spot Size | 1.44 cm² (SE to K141973, different from K123483's 1.2 cm², but deemed SE for overall comparison) |
| Fluence | 1-120 J/cm² (SE) |
| Irradiance | 0.7-347.8 W/cm² (SE to K141973, different from K123483's 600 W/cm², but deemed SE for overall comparison) |
| Frequency | 0.5-15Hz (Discussed difference from predicates, but deemed SE for overall comparison) |
| Pulse Duration | 5-400ms (Discussed difference from predicates, but deemed SE for overall comparison) |
| Power Supply | AC 110V/60Hz (SE) |
| Dimension | 450mm×550mm×380mm (Discussed difference from predicates, but deemed SE for overall comparison) |
| Weight | 52 kg (Discussed difference from predicates, but deemed SE for overall comparison) |
2. Sample size used for the test set and the data provenance
- Not Applicable: No clinical test set data is presented in this 510(k) submission for the proposed device's performance. The review relies on non-clinical testing for compliance with standards and a comparison of technical specifications to predicate devices. The section explicitly states "No clinical study is included in this submission."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: No clinical test set and thus no ground truth established by experts is mentioned in this submission.
4. Adjudication method for the test set
- Not Applicable: No clinical test set requiring adjudication is mentioned.
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 tool for "human readers." Therefore, an MRMC comparative effectiveness study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is a physical medical device (laser system), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: For the purposes of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence fundamentally relies on:
- Compliance with recognized industry standards (e.g., IEC, ISO) through non-clinical testing.
- Comparison of technical specifications and intended use to legally marketed predicate devices.
- The "permanent hair reduction" definition references long-term stable reduction measured at 6, 9, and 12 months after treatment, but this is an indication for use definition and not performance data from the current submission.
8. The sample size for the training set
- Not Applicable: No training set data for an algorithm is relevant to this device submission.
9. How the ground truth for the training set was established
- Not Applicable: No training set data for an algorithm is relevant to this device submission.
§ 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.