(44 days)
The Diode Laser Therapy Systems are intended for hair reduction on all skin types (Fitzpatrick skin type I-VI).
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 Therapy Systems has one model WLA-01, which mainly consist of the main console, treatment hand piece and a foot switch. The treat hand piece consist of the laser aperture, laser emission indicator, laser emission and hand piece display screen. The main console consist of power switch, hand piece holder, LCD touch screen, emergency shut off, hand-grip grab bar, connector hand piece, access door, observation Window, power input, inlet, air switch, gate interlock connector, foot switch connector, vent, drain and fans. The device has an embedded software named Diode Laser Therapy Systems Control Software.
The principle of laser hair removal is selective photothermolysis, 808nm wavelength effectively penetrates deep into and absorbed by the target chromophore. The adequate pulse duration, energy density and epidermal cooling ensure an adequate thermal damage to the target tissue without damaging the surrounding tissue to achieve effective hair removal.
The laser window of the hand piece will contact the skin directly and the laser output will contact the skin through the window. The Diode Laser Therapy System is suitable for use in healthcare facility/hospital.
Here's an analysis based on the provided text, outlining the acceptance criteria and study information for the Diode Laser Therapy Systems:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (Set by device manufacturer or regulatory body) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Biocompatibility | No cytotoxic, sensitization, or irritation effects for tissue-contacting parts (laser aperture). | The device successfully passed cytotoxicity, sensitization, and irritation tests according to FDA Blue Book Memorandum #G95-1 and ISO 10993-1. (The laser aperture is considered tissue contacting for less than 24 hours). |
| Electrical Safety (ES) | Compliance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text), IEC 60601-2-22 Edition 3.1 2012-10, and IEC 60825-1: 2014. | The system complies with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text), IEC 60601-2-22 Edition 3.1 2012-10, and IEC 60825-1: 2014 standards for safety. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014. | The system complies with the IEC 60601-1-2:2014 standard for EMC. |
| Software Verification & Validation | Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for a "moderate" level of concern software. | Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "moderate" level of concern, indicating successfully met criteria for this risk level. |
| Clinical Performance (Hair Reduction) | (Implied by substantial equivalence) Achieve "permanent hair reduction," defined as a 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, for all skin types (Fitzpatrick I-VI). | No new clinical studies were conducted for this submission. The device's equivalency was established by comparing its technological characteristics (e.g., wavelength, energy density, pulse width, frequency, cooling system) and indications for use to legally marketed predicate devices (K152898 and K141063), which are presumed to have met this clinical performance standard. The document explicitly states: "no clinical studies were needed to support this 510(k) Premarket Notification." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. The submission states, "no clinical studies were needed to support this 510(k) Premarket Notification." The performance data submitted was for non-clinical aspects (biocompatibility, electrical safety, EMC, software V&V). These tests were conducted on the device itself or its components.
- Data Provenance: The origin of the non-clinical test data (biocompatibility, electrical safety, EMC, software V&V) is not specified as a country of origin in the provided text. It is assumed to be internal testing or conducted by accredited labs on behalf of the manufacturer, Wingderm Electro-Optics Ltd. (China). The data is described as "performance data were provided in support of the substantial equivalence determination," indicating it's retrospective relative to the 510(k) submission date.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable for the non-clinical tests.
- For clinical performance (hair reduction), the ground truth was established by prior studies or general acceptance of the predicate devices. The document does not specify experts or their qualifications for the predicate devices' studies.
4. Adjudication method for the test set
- Not applicable for the non-clinical tests.
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
- No MRMC comparative effectiveness study was done. This device is a laser therapy system, not an AI-assisted diagnostic or interpretive device that would typically involve human readers.
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 standalone algorithm. Its software is embedded and controls device function, but it doesn't operate as an "algorithm only" in the sense of AI or diagnostic software.
7. The type of ground truth used
- For non-clinical tests (biocompatibility, electrical safety, EMC, software V&V): The ground truth is the adherence to established international and national standards (e.g., ISO 10993, ANSI AAMI ES60601-1, IEC 60601-1-2, FDA software guidance). Passing these tests constitutes meeting the "ground truth" for safety and performance in these areas.
- For clinical performance (hair reduction): The ground truth for hair reduction efficacy is based on the performance of the predicate devices, which are legally marketed and presumed to achieve "permanent hair reduction" as defined. The substantial equivalence argument relies on the subject device operating on the same principles and having comparable technical specifications to achieve the same clinical outcome as the already-cleared predicates.
8. The sample size for the training set
- Not applicable. This device does not use machine learning or AI models that require a "training set" in the conventional sense. The "training" for the software would involve traditional software development and testing cycles, not data-driven machine learning.
9. How the ground truth for the training set was established
- Not applicable (as the device does not use a "training set" in the AI/ML context).
§ 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.