(74 days)
The US 450 Diode Laser Equipment 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.
US450 Diode Laser Equipment is a device which adopts the high-energy and continuous diode laser to realize the conversion of electricity, light and heat energy, and thus achieves disease treatment. Therefore, this is a laser therapeutic product that integrates laser technology, electronic technology, computer science and medical science.
Under the control of microprocessor, laser power supply can provide the adjustable constant current for the laser module, the high power laser diode in the laser module can transform the electric energy into the light, generate the continuous laser beam with a wavelength of 808mm. Semiconductor laser used for hair removal is mainly based on the principle of selective photothermal action, that is, a specific wavelength of laser can only be selectively absorbed by the target color base.
US450 Diode Laser Equipment consists of power supply system, microprocessor control system, operation display system, cooling system, treatment handle and safety alarm system.
This document is a 510(k) summary for the US 450 Diode Laser Equipment, a device intended for hair reduction. The content focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance data from a specific clinical study for an AI/algorithm-based device.
Therefore, many of the requested elements for an AI/algorithm-based device (e.g., sample size for test set with data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or not available within this document. This submission primarily relies on non-clinical testing and comparison with a predicate device to establish safety and effectiveness.
Here’s an attempt to answer the questions based only on the provided text, indicating when information is not applicable or not present.
Device: US 450 Diode Laser Equipment
Intended Use: 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.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device (Diode Laser Hair Removal System, Model:M-DL100, K162659) and compliance with relevant safety and performance standards. The "performance" in this context refers to the device's technical specifications and safety profile, rather than a clinical success rate, as no clinical study was conducted for this submission.
Table of Acceptance Criteria and Reported Device "Performance" (Comparison to Predicate Device)
| Feature/Standard | Acceptance Criteria (Implicit - Substantial Equivalence / Standard Compliance) | Reported Device Performance (Proposed Device) | Remark for Equivalence |
|---|---|---|---|
| Classification | 21 CFR 878.4810, Class II, Product Code GEX, General & Plastic Surgery Panel | 21 CFR 878.4810, Class II, Product Code GEX, General & Plastic Surgery Panel | SAME |
| Indication for 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 hair regrowing at 6, 9, 12 months post-treatment. Prescription use. | Identical to predicate device. Prescription use. | SAME |
| Principle of Operation | Diode laser | Diode laser | SAME |
| Laser Type | Diode laser | Diode laser | SAME |
| Laser Classification | Class IV | Class IV | SAME |
| Laser Wavelength | 808nm | 808nm | SAME |
| Spot Size | 1.44 cm² (Predicate) | 10x10 mm² (1 cm²) | Different: Noted that it “only relate to the treatment area size, will not affect the effectiveness and safety.” |
| Energy Density | 1-120 J/cm² (Predicate) | 5-80 J/cm² | Different: Proposed device's range is within the predicate's range and its maximum is smaller. Justified by safety tests and comparison to a reference device (K221312) with a lower energy density that is effective. |
| Pulse Frequency | 0.5-15 Hz (Predicate) | 0.5-3 Hz | Different: Proposed device's range is within the predicate's range. Justified by safety and performance tests. |
| Pulse Duration | 5-400 ms | 5-400 ms | SAME |
| Power Supply | AC 110V/60Hz (Predicate) | AC 110V/50/60Hz | Different: Justified by electrical safety and EMC tests. |
| Dimension | 450mm x 550mm x 380mm (Predicate) | 47 x 47 x 132 cm | Different: Justified by compliance with IEC 60601-1 for mechanical performance. |
| Weight | 52 kg (Predicate) | 68 kg | Different: Justified by compliance with IEC 60601-1 for mechanical performance. |
| Electrical Safety | Compliance with IEC 60601-1 | Complies with IEC 60601-1:2005, AMD1:2012 with US National Differences A | SAME |
| EMC | Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2:2014 | SAME |
| Patient Contact Material | Sapphire in handpiece (Predicate) | Handle head: Aluminum; Ophthalmic Lens: Aluminum oxide | Different: Justified by passing ISO 10993 series tests. |
| Biocompatibility (Cytotoxicity) | No toxicity (ISO 10993-5) | No toxicity (ISO 10993-5) | SAME |
| Biocompatibility (Irritation) | No irritation (ISO 10993-10) | Applied sample did not induce irritation to skin (ISO 10993-10) | SAME |
| Biocompatibility (Sensitization) | No sensitization (ISO 10993-10) | No significant evidence of causing skin sensitization (ISO 10993-10) | SAME |
Study Details (Focusing on the Provided Document)
This document is a 510(k) summary, which inherently focuses on comparing a new device to a legally marketed predicate device to demonstrate substantial equivalence, rather than providing results from a detailed clinical trial or an AI/algorithm performance study.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The submission explicitly states: "No clinical study is included in this submission." The evaluation relies entirely on non-clinical tests (electrical safety, EMC, biocompatibility, performance tests demonstrating compliance with standards) and comparison to a predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. As no clinical study or test set with ground truth annotations was conducted or used in this 510(k) submission, this information is not applicable.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No clinical test set.
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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:
- N/A. This device is a laser hair removal system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This applies to an AI/algorithm, which this device is not. The "performance test" mentioned for the device itself would be the closest analogue, confirming the laser system's physical output parameters (energy, frequency, etc.) meet specifications and ensure safety and effectiveness.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. No ground truth in the context of clinical interpretation/diagnosis was established for this submission. The "ground truth" for the device's performance is adherence to established engineering standards (e.g., IEC 60601-1, ISO 10993) and the demonstrated technical specifications being within acceptable ranges or justified differences compared to a predicate device with known effectiveness.
- For the intended use of "permanent hair reduction," the definition is provided: "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." However, no new clinical data demonstrating this outcome with the proposed device is provided.
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The sample size for the training set:
- N/A. This is not an AI/algorithm-based device.
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How the ground truth for the training set was established:
- N/A. This is not an AI/algorithm-based 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.