Search Results
Found 1 results
510(k) Data Aggregation
(200 days)
Intelligence LaserComb
The Intelligence Laser Comb (Model: YTLC001-W ) is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.
The Intelligence Laser Comb (Model: YTLC001-W) is a home-use comb-shaped low level laser therapy (LLLT) device that emits laser light with the intention to promote hair growth in men and women. The device provides distributed laser to the scalp at 655+/-10nm while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The Laser Comb is an over-the-counter (OTC) device intended for home-use. The Laser Comb works by providing laser energy to stimulate hair follicles. For optimal results, the laser must not be blocked by the hair and must have an unobstructed path to the scalp. The Laser Comb has teeth that part the hair and allow the maximum amount of laser energy to reach the scalp. The Laser Hair Growth Comb design with plastic Mainframe, it is composed of PCB circuit board, Power Button, Indicator Light, Red Laser Light, Teeth, USB charging port. And the device is equipped with one internal rechargeable lithium battery (3.7 V d.c. 500mA) that can be charged directly by external adapter. The device uses beep and vibrate to alert the user to the next step during treatment.
The provided document is a 510(k) Summary for the Intelligence Laser Comb (Model: YTLC001-W). This document does not describe acceptance criteria for a "device performance" relating to the intended use (hair growth) or a study proving it meets such criteria. Instead, it details that clinical performance is not deemed necessary and focuses on proving substantial equivalence to a predicate device through conformity to recognized international standards for electrical safety, electromagnetic compatibility, and biocompatibility.
Here's a breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for the device's efficacy in promoting hair growth, nor does it report on such performance for the subject device. It relies on demonstrating substantial equivalence to a predicate device which does have an indication for hair growth.
The acceptance criteria and reported performance relate to safety and compliance with standards:
| Acceptance Criteria (Standards Conformance) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-1 Fifth edition 2018-08 (Evaluation and testing within a risk management process) | Biocompatibility evaluation conducted in accordance with ISO 10993-1. |
| ISO 10993-5:2009 (Tests for In Vitro cytotoxicity) | The battery of testing was performed to, and passed, ISO 10993-5 (In Vitro cytotoxicity). |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | The battery of testing was performed to, and passed, ISO 10993-10 (irritation and skin sensitization). |
| Electrical Safety: | |
| IEC 60601-1:2012 (General Requirements for Basic Safety and Essential Performance) | Electrical safety testing was performed to, and passed, IEC 60601-1. |
| IEC 60601-1-11:2015 (Requirements for medical electrical equipment and systems used in the home healthcare environment) | Electrical safety testing was performed to, and passed, IEC 60601-1-11. |
| IEC 60825:2014 (Safety of laser products - Part 1: Equipment classification and requirements) | Electrical safety testing was performed to, and passed, IEC 60825:2014. Classification according to IEC60825-1 is Class 3R, which matches the predicate device. |
| Electromagnetic Compatibility (EMC): | |
| IEC 60601-1-2:2014 (Collateral standard: Electromagnetic compatibility) | EMC safety testing was performed to, and passed, IEC 60601-1-2. |
| Software Verification and Validation: | |
| FDA "Guidance for Premarket Submissions and for Software Contained in Medical Devices" Software Life Cycle Processes | Software verification and validation test was performed to these FDA guidance and IEC 62304:2006+AMD1:2015 Medical Device Software. No specific performance metrics or acceptance criteria are detailed beyond "test was performed" and "conformance" to these. |
| IEC 62304:2006+AMD1:2015 Medical Device Software (Software Life Cycle Processes) | Software verification and validation test was performed to this standard. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Summary for clinical test: Clinical performance is not deemed necessary." Therefore, there is no test set, sample size, or data provenance related to the device's efficacy in promoting hair growth. The data provenance for the safety and compatibility tests is not specified, but the applicant company is located in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical performance study was conducted or deemed necessary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance study was conducted or deemed necessary.
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. This device is a low-level laser therapy device for hair growth, not an AI-based diagnostic or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical laser comb, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance study was conducted or deemed necessary for hair growth efficacy. For the safety and compliance tests, the "ground truth" is adherence to the specified international standards.
8. The sample size for the training set
Not applicable, as no clinical performance study was conducted or deemed necessary, and this is not an AI/machine learning device that requires a training set for its intended use.
9. How the ground truth for the training set was established
Not applicable.
Ask a specific question about this device
Page 1 of 1