(57 days)
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
The IPL Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with ice compress function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use. The IPL Hair Removal Device includes ZHF-IPL-II and ZHF-IPL-III two models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly in product appearance and its spot size of the treatment window, output energy, and display form, but these differences do not affect or change the intended use of the device. The model difference is embodied in #1) the spot size of the ZHF-IPL-II is 3.6cm2 and the corresponding output energy is 2.64.4J/cm²; the spot size of the ZHF-IPL-III is 4.1cm² and the corresponding output energy is 2.43.7J/cm²; #2) the display form of ZHF-IPL-II is LCD display screen and indicator light, and the display form of ZHF-IPL-III is indicator bar and light.
This FDA 510(k) summary for the IPL Hair Removal Device (K222316) focuses on establishing substantial equivalence to a predicate device (K221001) rather than detailing a study with specific acceptance criteria related to efficacy (hair removal performance). The performance data provided primarily addresses safety.
Therefore, for aspects related to hair removal efficacy, the document does not contain the level of detail typically found in a clinical study report proving the device meets specific performance acceptance criteria. It relies on the substantial equivalence to the predicate device, which presumably demonstrated efficacy.
However, I can extract the acceptance criteria and performance related to device safety and general design.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility Safety | ISO 10993-5: Tests for In Vitro Cytotoxicity | Passed |
| ISO 10993-10: Tests for Irritation and Skin Sensitization | Passed | |
| Electrical Safety | IEC 60601-1-2: Electromagnetic compatibility | Passed |
| IEC 60601-1: Basic safety and essential performance | Passed | |
| IEC 60601-1-11: Home Healthcare Environment | Passed | |
| IEC 60601-2-83: Home Light Therapy Equipment | Passed | |
| Eye Safety | IEC 62471: Photobiological safety of lamps and lamp systems | Passed |
| Software Verification & Validation | All software requirement specifications met and hazards mitigated to acceptable risk levels (for moderate level of concern software) | All software requirement specifications met and all software hazards have been mitigated to acceptable risk levels. |
Missing Information Regarding Efficacy Studies:
The document does not provide the following information directly related to demonstrating hair removal efficacy:
- Sample size used for the test set and the data provenance: Not applicable as no efficacy study detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for an efficacy study outlined in this document.
- The sample size for the training set: Not applicable as no efficacy study detailed.
- How the ground truth for the training set was established: Not applicable.
Explanation for Missing Efficacy Data:
This document is a 510(k) summary for a premarket notification. The primary goal of a 510(k) is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to re-prove efficacy through new, extensive clinical trials if the predicate device's efficacy is well-established for the same intended use.
The statement under "VI. Comparison of Technological Characteristics With the Predicate Device" clarifies this: "Any minor differences between the subject device and the listed predicate device do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use."
The "Performance Data" section (VII) explicitly states: "The following performance data were provided in support of the substantial equivalence determination." This section then details the safety and software validation tests listed in the table above, but not a separate clinical trial for hair removal efficacy. The assumption is that because the device is substantially equivalent to a cleared predicate device with demonstrated efficacy, new efficacy studies are not required for this 510(k) clearance.
§ 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.