FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The IPL Home Use Hair Removal Device is the professional IPL in five levels and offers a beauty experience in comfort of your own home as well as has been designed with unique features for simple, relaxed and effective hair removal.

IPL Home Use Hair Removal Device includes D-1199, D-T099, D-T018, D-T003B, D-T003W, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, 1196B, D-1196C, D-1196C, D-1196C1, D-T099K, D-T012, D-T012W sixteen models. All have adopted basically identical structure design, consisting of IPL host and power adapter two parts, which the host is mainly composed of lamp cartridge, display screen, power and/or level button, skin sensor, fan, flash button and DC socket. D-T099K, D-T099KM, D-1196B, D-1196W do not contain the lee-Cooling function. D-1199, D-T018, D-T019, D-T003B, D-T003W, D-T019Y, D-T019Y, D-1196C, D-1196C1 have Ice-Cooling function and only perform the hair removal and cold compress function simultaneously. D-T012W have lce-Cooling function and it is able to perform the hair removal and cold compress function simultaneously or separately.

AI/ML Overview

This is an FDA 510(k) summary for an IPL Home Use Hair Removal Device. The document establishes substantial equivalence to a predicate device, which is the primary mechanism for FDA clearance of Class II devices like this.

Based on the provided text, a formal study proving the device meets specific acceptance criteria for a new AI/algorithm-driven medical device, as typically described in an acceptance criteria table, was not conducted or reported in this 510(k) summary.

This 510(k) focuses on demonstrating that the IPL Home Use Hair Removal Device is substantially equivalent to legally marketed predicate devices, not on proving new clinical performance through a comparative effectiveness study involving AI or human readers. The "Performance Data" section primarily addresses safety (biocompatibility, electrical safety, EMC, eye safety, software V&V) rather than clinical efficacy through human subject testing.

Therefore, many of the specific details requested in the prompt, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set" related to an AI/algorithm, are not applicable to the information provided in this 510(k) summary.

Here's an analysis based on the information available:

Acceptance Criteria and Device Performance (Not Applicable in the context of AI/Algorithm Performance)

Since this is an IPL hair removal device and not an AI/algorithm-driven diagnostic or assistive device in the typical sense for which such a table would be generated, there are no specific AI model performance acceptance criteria or reported metrics like sensitivity, specificity, or AUC. The "acceptance criteria" here are implicitly meeting the safety and performance standards demonstrated by the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Summary of Testing)
Biocompatibility:
- No cytotoxicity	Passed ISO 10993-5:2009
- No skin sensitization	Passed ISO 10993-10:2021
- No skin irritation	Passed ISO 10993-23:2021
Electrical Safety & EMC:
- Complies with general safety standards	Passed IEC 60601-1
- Complies with EMC standards	Passed IEC 60601-1-2
- Complies with home healthcare environment standards	Passed IEC 60601-11
- Complies with light therapy equipment standards	Passed IEC 60601-2-83
Eye Safety:
- Complies with photobiological safety	Passed IEC 62471
Software V&V:
- Software requirements met; risks mitigated	System validation testing demonstrated compliance
Clinical Efficacy (Non-AI/Algorithm):
- Safe and effective for hair removal, performing as well as predicate device	Clinical performance data (not detailed in summary, implied similar to predicate due to substantial equivalence) supports safety and effectiveness.
- Similar intended use, mode of action, and operational characteristics to predicate.	Confirmed (see comparison table).

Study Details (As applicable from the 510(k) Summary):

Sample sizes used for the test set and the data provenance:
- Test Set: No specific "test set" in the context of an algorithmic performance study for an AI device. The testing outlined (biocompatibility, electrical safety, etc.) is laboratory-based and engineering verification/validation, not a clinical trial with a "test set" of patient data for an algorithm. Clinical performance is demonstrated by the substantial equivalence to the predicate device, which implicitly means its performance for hair removal is considered equivalent without a new clinical study.
- Data Provenance: Not specified for any performance testing, but the company is Shenzhen Beauty Every Moment intelligent electric Co., Ltd. (China). This suggests testing was likely conducted in China or by labs utilized by the manufacturer. The document doesn't mention retrospective or prospective human data collection for efficacy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of an expert-adjudicated ground truth for an AI algorithm in this 510(k) summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No such clinical "test set" or adjudication method for an algorithm is described.
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:
- No. An MRMC comparative effectiveness study was not conducted or reported here. This is an IPL hair removal device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for an AI algorithm. For the function of the device itself, the "ground truth" for "hair removal" would typically be visual assessment of hair reduction, but no such clinical study specific to this submission is detailed. The performance relies on substantial equivalence to the predicate.
The sample size for the training set:
- Not applicable. There is no AI algorithm being trained mentioned in this submission.
How the ground truth for the training set was established:
- Not applicable. There is no AI algorithm being trained mentioned in this submission.

In summary: This 510(k) clearance document for an IPL Home Use Hair Removal Device relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. This means that its safety and performance (including efficacy for hair removal) are considered equivalent based on engineering design, specifications, and device characteristic comparisons, supplemented by standard safety testing (biocompatibility, electrical safety, eye safety, software V&V). It does not involve the type of clinical performance study required for novel AI/algorithm-driven diagnostic or therapeutic devices that directly assist or interpret medical data for human users or make decisions.

Summary

Regulation Number and Section

§ 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.