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510(k) Data Aggregation
(83 days)
IPL Hair Removal Device 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.
IPL Hair Removal Device is the fast professional IPL with 6 levels for DH4, 8 levels for DH5, DH5 Plus and DH5 Max, and offers a beauty removal.
IPL Hair Removal Devices of models: DH4, DH5 Plus and DH5 Max consist of IPL host and power adapter. The host is mainly composed of hair removal lamp, power/level button, skin sensor, thermovent (fan), flash button and DC socket.
The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Devices of models DH5 Max have the cooling function, which will be activated throughout the whole process to cool down the treatment area's temperature and provide the user with a better using experience.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max), based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance related to hair removal efficacy. Instead, it focuses on the device's adherence to safety and performance standards for its operating characteristics. The criteria for equivalence are primarily based on the comparison of technological characteristics with predicate devices.
| Acceptance Criteria (Implied/Derived from Comparison) | Reported Device Performance (from "Technological Comparison" and "Non-Clinical Tests Summary") |
|---|---|
| Functional Equivalence: | |
| Intended Use | Same as predicate (unwanted hair removal, permanent reduction in hair regrowth at 6, 9, and 12 months) |
| Mode of Action | Same as predicate (Intense Pulsed Light) |
| Source Energy and Power Supply | Same as predicate (external adapter with 100-240V~, 50/60Hz) |
| Light Source | Same as predicate (Intense Pulsed Light) |
| Energy Medium | Same as predicate (Xenon Arc Flashlamp) |
| Wavelength | Same as predicate (510-1200nm) |
| Safety and Performance Characteristics: | |
| Spot Size | DH4: 3.0cm²; DH5, DH5 Plus, DH5 Max: 3.0cm². This is different from the primary predicate (K173813) but the energy density is within the predicate's range, so deemed not to raise safety/effectiveness issues. |
| Energy Density | DH4: 2.0-4.0 J/cm²; DH5, DH5 Max: 2.3-4.5 J/cm². This is within the range of the primary predicate (1.8-5.1 J/cm²). |
| Pulse Duration | 6.6-9.6ms. This is different from the primary predicate but within the minimum value range of both predicate devices, so deemed not to raise safety/effectiveness issues. |
| Output Energy Density Verification | Verified (Specific values or pass/fail not provided, assumed to meet internal specs and predicate comparison). |
| Pulse Duration Time Verification | Verified (Specific values or pass/fail not provided, assumed to meet internal specs and predicate comparison). |
| Valid Times of Flashes Verification | Verified (Specific values or pass/fail not provided, assumed to meet internal specs). |
| Biocompatibility (Cytotoxicity) | Compliant with ISO 10993-5: 2009. |
| Biocompatibility (Skin Sensitization) | Compliant with ISO 10993-10: 2021. |
| Biocompatibility (Irritation) | Compliant with ISO 10993-23: 2021. |
| Electrical Safety | Compliant with IEC 60601-1:2005/AMD1:2012/AMD2:2020. |
| Electromagnetic Compatibility | Compliant with IEC 60601-1-2:2014+A1:2020. |
| Home Healthcare Environment Compliance | Compliant with IEC 60601-1-11:2015/AMD1:2020. |
| Home Light Therapy Equipment Safety | Compliant with IEC 60601-2-83:2019. |
| Photobiological Safety | Compliant with IEC 62471:2006. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical test is not applicable, thus, there's no clinical data for the device." This indicates that there was no test set with human subjects for evaluating efficacy or clinical performance. The evaluation was based on non-clinical (engineering and lab) tests and comparison to predicate devices. Therefore, sample size and data provenance for a "test set" in a clinical context are not relevant to this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As there was no clinical test set, there were no experts used to establish ground truth in a clinical sense. The "ground truth" for the non-clinical tests would be established by the engineering and quality control standards defined by the listed ISO and IEC standards.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
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. The device is an IPL hair removal device, not an AI-assisted diagnostic or interpretation tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to an IPL hair removal device. The device's "standalone performance" is implicitly covered by the non-clinical tests verifying its physical and electrical characteristics according to established standards. It's a direct-use medical device, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is defined by the international and national standards listed (e.g., ISO 10993 series, IEC 60601 series, IEC 62471). These standards set the benchmarks and methodologies for evaluating biocompatibility, electrical safety, electromagnetic compatibility, and photobiological safety. For the comparison to predicate devices, the "ground truth" is the technical specifications and cleared indications for use of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. The device is not an AI/ML algorithm that requires a training set in the conventional sense. Its design and manufacturing processes might involve internal testing and validation, but not a "training set" like for predictive models.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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