(70 days)
IPL HAIR REMOVAL HANDSET is an over-the-counter device intended for removal of unwanted body and/or facial hair.
The IPL HAIR REMOVAL HANDSET 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. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon Quartz Lamp Tube to emit light and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot trigger a pulse emitting.
The provided document is a 510(k) summary for the IPL HAIR REMOVAL HANDSET, Model: IPL-666. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria or extensive clinical study outcomes.
Therefore, much of the requested information regarding specific acceptance criteria, device performance, sample sizes, expert involvement, efficacy studies (MRMC or standalone), and training set details for AI/algorithm performance cannot be extracted from this document. This type of document typically focuses on technical and safety equivalence to a legally marketed predicate.
However, I can provide the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria for device performance related to hair removal efficacy. Instead, it relies on demonstrating substantial equivalence to a predicate device based on technical characteristics and safety testing.
| Acceptance Criteria (Not Explicitly Stated for Performance) | Reported Device Performance (Summary of Technical Characteristics) |
|---|---|
| Safety and Functionality Standards: | |
| Electrical Safety (IEC 60601-1, -1-2, -1-11) | Device complies with these standards. |
| Particular Requirements for Home Light Therapy (IEC 60601-2-83) | Device complies with this standard. |
| Photobiological Safety (IEC 62471) | Device complies with this standard. |
| Biocompatibility (ISO 10993-5, -10) | Skin-contacting materials comply with these standards. |
| Software Verification & Validation | Performed according to FDA guidance. |
| Technical Design (Compared to Predicate): | |
| Light source: Intense Pulsed Light | Same as predicate. |
| Energy medium: Xenon Quartz Tube / Xenon lamp | Similar to predicate (Xenon Arc Flashlamp / Xenon lamp). |
| Wavelength range (nm): 470nm ~1100nm | Similar to predicate (475nm |
| Energy density (J/cm²): Max 2.49J/cm² | Similar to predicate (Max 5J/cm² for predicate, 2.0-4.5 J/cm² for reference). |
| Spot size (cm²): 3cm² | Same as predicate (1.72 cm² or 3.02 cm² for predicate, various for reference). |
| Pulse duration: 11.5-15ms | Similar to predicate (11-12ms for predicate, 7.5-14ms for reference). |
| Output intensity levels: 5 levels | Same as predicate. |
| Skin sensor: Present | Same as predicate. |
| Intended use: Removal of unwanted body and/or facial hair | Same as predicate. |
| Applicable skin phototypes: Fitzpatrick I-V | Same as reference device. Unknown for predicate. |
2. Sample size used for the test set and the data provenance
The document does not detail a clinical test set with human subjects for performance evaluation. The "tests" mentioned are non-clinical (electrical safety, biocompatibility, software V&V) and do not involve a "test set" in the context of clinical performance data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document does not describe a clinical test set requiring expert-established ground truth for efficacy.
4. Adjudication method for the test set
Not applicable, as no clinical test set for efficacy is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence based on technical specifications and safety testing, not direct clinical performance comparison with human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is an IPL hair removal handset, which is a physical medical device, not an AI/algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The type of ground truth used
Not applicable, as no clinical performance study requiring ground truth for efficacy is described. The "ground truth" in this context would generally relate to measured hair reduction, which is not presented here.
8. The sample size for the training set
Not applicable, as this is a physical device and not an AI/algorithm-based product requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a physical device and not an AI/algorithm-based product requiring a 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.