(88 days)
Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Hair Removal Device (Model: R3C16-P, R3C16-G; R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro), is an over-the-counter, home-use and personal device for hair reduction based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. Hair Removal Device includes two series (R3C16 series) with a total of 10 models. The two series products adopt identical intended use, similar performance and operation, consisting of IPL host and power adapter, which the host is mainly composed of lamp tube, filter, display screen, buttons, thermoelectric cooler, fan, and DC socket. The device is only powered by the external power adapter. The device is fitted with a skin sensor to detect appropriate skin contact, if the treatment window of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission is by manual finger switch or auto light emission. All models of the Hair Removal Device have a cooling function for a better hair removal experience, but the main difference is that the model with "Pro" in the model name is equipped with sapphire while the model without "Pro" uses metal treatment window surface.
This 510(k) summary provides limited information regarding specific acceptance criteria and detailed study results for the Hair Removal Device. However, based on the provided text, here's an analysis of what can be extracted.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it relies on a comparison to predicate devices and adherence to various safety and performance standards.
We can infer the intent of some acceptance criteria by looking at the "Comparison Elements" table on pages 7-8 and the "Non-Clinical Testing" section on page 9. The underlying acceptance is that the subject device's characteristics and performance are "similar" or "same" to the predicate devices and meet the specified international standards for medical electrical equipment and photobiological safety.
| Acceptance Criteria (Inferred) | Reported Device Performance (from Comparison Table) |
|---|---|
| Intended Use | "Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair." (Same as Predicate 1, similar to others which also mention permanent reduction) |
| Prescription or OTC | OTC (Same as all listed predicates/references) |
| Source Energy | An external power supply (Same as all listed predicates/references) |
| Power Supply | 100~240V, 50/60Hz (Same as Predicate 1 and Reference 1, similar to Predicate 2) |
| Dimensions (mm) | R3C16 series: 1857040mm; R3505 series: 19811751mm (Different from Predicate 1 and Reference 1, but this is a size difference, not necessarily a performance failure) |
| Sterilization | Not required (Same as all listed predicates/references) |
| Light Source | Intense Pulsed Light (Same as all listed predicates/references) |
| Energy Medium | Xenon Arc Flashlamp (Same as all listed predicates/references) |
| Wavelength Range | 530~1200nm (Same as Predicate 1, similar to others in the 510-1200nm range) |
| Energy Density | R3C16: 1.56J/cm² |
| Spot Size | R3C16: 3.2±0.25cm²; R3C16 Pro: 3.6±0.25cm²; R3505: 2.8±0.25cm²; R3505 Pro: 3.3±0.25cm² (Similar to predicate devices which range from 3cm² to 4.2cm²) |
| Pulse Duration | R3C16 series: 6-11ms; R3505 series: 11~12ms (Similar to predicate devices which range from 2ms to 25ms) |
| Pulsing Control | Finger switch (Same as all listed predicates/references) |
| Delivery Device | Direct illumination to tissue (Same as all listed predicates/references) |
| Output Intensity Level | 9 levels (Same as Predicate 1 and Reference 1) |
| Software/Firmware/Microprocessor Control? | Yes (Same as Predicate 1, 2, 3 and Reference 1) |
| Biological Evaluation (Cytotoxicity) | Compliant with ISO 10993-5: 2009 |
| Biological Evaluation (Skin Sensitization) | Compliant with ISO 10993-10: 2021 |
| Biological Evaluation (Irritation) | Compliant with ISO 10993-23: 2021 |
| Electrical Safety | Compliant with IEC 60601-1: 2020 |
| Electromagnetic Compatibility (EMC) | Compliant with IEC 60601-1-2: 2020 |
| Home Healthcare Environment Safety | Compliant with IEC 60601-1-11: 2020 |
| Home Light Therapy Equipment Safety | Compliant with IEC 60601-2-83: 2022 |
| Photobiological Safety | Compliant with IEC 62471: 2006 |
| Usability | Compliant with IEC 60601-1-6: 2020 |
| Overall Safety and Effectiveness | "as safe, as efforms as well as the legally marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states "VIII. Clinical Testing: Not applicable."
This means there was no clinical test set for evaluating the device's hair removal efficacy and safety on human subjects as part of this 510(k) submission. Therefore, details like sample size, country of origin, or retrospective/prospective nature are not provided for efficacy testing.
The "non-clinical testing" mentioned primarily refers to bench testing and adherence to international safety and performance standards for medical devices and photobiological safety. For these tests, specific sample sizes (e.g., number of devices tested for electrical safety, materials tested for biocompatibility) are typically defined by the respective standards, but these details are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical testing was applicable or performed for this 510(k) submission, there was no clinical test set for which ground truth needed to be established by experts for efficacy. The evaluation was based on non-clinical characteristic comparisons and technical standard compliance.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication for ground truth was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Done
No. The document explicitly states "VIII. Clinical Testing: Not applicable." An MRMC study would be a type of clinical comparative effectiveness study, which was not done.
6. Standalone Performance Done
The performance evaluation in this 510(k) is primarily a standalone assessment of the device's technical specifications and compliance with safety standards. The comparison to predicates is to demonstrate "substantial equivalence" based on similar characteristics and the device meeting the same technical and safety requirements. The non-clinical tests (e.g., biocompatibility, electrical safety, photobiological safety) are assessments of the device itself (standalone).
7. Type of Ground Truth Used
Given the "Clinical Testing: Not applicable" statement, there was no clinical "ground truth" related to hair removal efficacy established or used in this submission. The "ground truth" for the non-clinical tests would be the requirements and limits defined by the referenced international standards (e.g., IEC, ISO standards). For example, the ground truth for cytotoxicity testing is whether the material shows cytotoxic effects according to the criteria in ISO 10993-5.
8. The Sample Size for the Training Set
Not applicable. The device is a hardware product for hair removal, not an AI/ML algorithm that requires a training set in the typical sense. The "software/firmware/microprocessor control" mentioned refers to embedded control systems for device operation (e.g., intensity levels, safety features), not for learning or diagnostic purposes that would require a large training dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of an AI/ML algorithm training set.
§ 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.