(56 days)
Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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.
Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with a lamp that can emit single pulse, double pulse or triple pulse per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
This FDA 510(k) clearance letter pertains to an Ice Cooling IPL Hair Removal Device, not an AI/algorithm-based diagnostic device. Therefore, the information typically requested in your prompt regarding acceptance criteria and studies proving the device meets those criteria (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this type of medical device clearance.
The 510(k) summary for this IPL device focuses on demonstrating substantial equivalence to predicate devices through:
- Identical Intended Use: Hair removal and permanent reduction in hair regrowth.
- Similar Technological Characteristics: Comparison of physical dimensions, power supply, light source, energy medium, wavelength range, energy density, output energy, spot size, pulse duration, pulsing control, delivery device, output intensity levels, and software/firmware. Minor differences are addressed by showing they do not raise new safety or efficacy concerns.
- Performance Data (Non-Clinical Testing):
- Biocompatibility Testing: Ensuring materials in contact with the body are safe (per ISO 10993 series).
- Electrical Safety and EMC (Electromagnetic Compatibility): Compliance with relevant IEC 60601 standards to ensure electrical safety and proper operation in the presence of electromagnetic disturbances.
- Light Safety: Compliance with IEC 62471 for photobiological safety.
- Software Verification and Validation: Ensuring software functions correctly and mitigates hazards, consistent with a "Basic Documentation Level."
- Usability: Evaluation and validation per IEC 60601-1-6 and FDA guidance on Human Factors and Usability Engineering.
To directly answer your prompt, but acknowledging its non-applicability to this specific device:
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A table of acceptance criteria and the reported device performance:
Acceptance Criteria (General for IPL Device) Reported Device Performance (Summary of Non-Clinical Testing) Biocompatibility (Safety of body-contacting parts) Passed ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation), ISO 10993-5 (in vitro cytotoxicity). Electrical Safety (Prevention of electric shock, fire, etc.) Passed IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare), IEC 60601-2-57 (non-laser therapeutic equipment), IEC 60601-2-83 (home light therapy equipment). Electromagnetic Compatibility (EMC) Passed IEC 60601-1-2 (EMC requirements and tests). Light Safety (Patient eye/skin safety from light emission) Passed IEC 62471 (photobiological safety of lamps and lamp systems). Software Functionality and Safety Software documentation consistent with "Basic Documentation Level" submitted. System testing demonstrated all software requirements met and hazards mitigated to acceptable levels. Usability (Safe and effective use by intended user) Evaluated and validated according to IEC 60601-1-6 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." Performance within specified output parameters (Energy density, wavelength, etc.) Output specifications (e.g., energy density 1.8-6.67 J/cm², wavelength 550-1200nm) are provided and considered substantially equivalent to predicates, with minor differences justified as not raising safety/efficacy issues. Temperature Test Report and Usability evaluation conducted to verify safe multi-pulse use. -
Sample sizes used for the test set and the data provenance: Not applicable to this type of device and submission. The "test set" here refers to specific non-clinical engineering tests (e.g., electrical safety, biocompatibility) where sample sizes are determined by standard testing protocols for equipment, not by a patient/image dataset. The data provenance is primarily from the manufacturer's internal testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an IPL device is established through engineering specifications and physical measurements, and by adherence to recognized consensus standards for safety and performance, not by expert interpretation of clinical data in the context of diagnostic AI.
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Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 apply to clinical data interpretation, typically in diagnostic studies.
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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: Not applicable. This is an IPL device, 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: Not applicable. There is no AI algorithm being evaluated for standalone performance in this submission.
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The type of ground truth used: For this device, "ground truth" refers to:
- Physical Measurements/Engineering Specifications: Ensuring the device operates within its stated parameters (e.g., energy output, wavelength).
- Compliance with Recognized Consensus Standards: Adherence to standards like IEC 60601 series, IEC 62471, and ISO 10993 series, which define safety and performance requirements.
- Usability Testing Outcomes: Observing real users to ensure the device can be used safely and effectively.
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The sample size for the training set: Not applicable. There is no "training set" in the context of an IPL device clearance, as it's not an AI/machine learning model.
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How the ground truth for the training set was established: Not applicable for the same reason as above.
§ 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.