Search Results

LLLT Laser Hair Growth Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.

Device Description

LLLT Laser Hair Growth Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of visible red light-emitting diodes at 650mm and 5mW each. LLLT Laser Hair Growth Cap includes three models, Hair Care 210, Hair Care 135 and Hair Care 210 (210 diodes) is the typical model, Hair Care 135 (135 diodes) and Hair Care 88 (88 diodes) are exactly the same as the Hair Care 210 regarding structure design, intended use, performance and operation, with the difference being the diode amount. Each model has three colors, which are white, hidden color and pool blue.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from Shenzhen CosBeauty Technology Co., Ltd. to the FDA for their LLLT Laser Hair Growth Cap. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

Absence of Clinical Study for Device Acceptance Criteria

Critically, the provided document does not report any clinical study data or acceptance criteria related to the device's efficacy in promoting hair growth. The submission focuses on demonstrating substantial equivalence to a predicate device (CAPOGEN Laser Cap, K201854) and a reference device (Lasercap Family of Lasers, K203826) primarily through non-clinical testing and comparison of technical specifications.

The provided text explicitly states in section (9) "Non-clinical studies and tests performed" and section (10) "Conclusion" that non-clinical testing was conducted to verify compliance with design specifications and safety standards. There is no mention of a clinical trial, performance study, or any data proving the device meets specific efficacy-related acceptance criteria for hair growth.

Therefore, I cannot provide information on:

A table of acceptance criteria and the reported device performance: No performance criteria for hair growth are stated, nor is performance data presented.
Sample size used for the test set and data provenance: No clinical test set is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a clinical test set is mentioned.
Adjudication method for the test set: No clinical test set is mentioned.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: No such study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
The type of ground truth used: No ground truth for clinical efficacy is mentioned.
The sample size for the training set: Not applicable as no AI algorithm or training set for clinical efficacy is mentioned.
How the ground truth for the training set was established: Not applicable.

What the document does describe are safety and performance standards for the device itself (e.g., electrical safety, biocompatibility, laser classification) and a comparison of its technical specifications to predicate devices to establish substantial equivalence.

The "Acceptance Criteria" for this 510(k) submission are therefore implied to be the successful demonstration of:

Substantial Equivalence: The subject device (LLLT Laser Hair Growth Cap) is as safe and effective as a legally marketed predicate device, as determined by technical comparison and non-clinical testing.
Compliance with Recognized Standards: The device meets applicable national and international consensus standards for medical electrical equipment, laser safety, and biocompatibility.

Here's what can be extracted regarding the device and its assessment:

Device Acceptance Criteria (Implied for 510(k) Substantial Equivalence and Safety):

Acceptance Criteria Category	Specific Criteria / Standard	Reported Device Performance / Compliance
I. Substantial Equivalence (Overall)	The device is as safe, as effective, and performs as well as the legally marketed predicate device (K201854, CAPOGEN Laser Cap). Its indications for use, technological characteristics, and treatment parameters are similar to the predicate and reference devices.	The document concludes that "LLLT Laser Hair Growth Cap is substantially equivalent to the predicate device" based on a detailed comparison of features, similar indications for use, and compliance with similar safety and performance standards.
II. Electrical Safety	Compliance with ANSI AAMI ES 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance).	"Non-clinical testings have been conducted to verify... complies with... ANSI AAMI ES 60601-1."
III. Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests).	"Non-clinical testings have been conducted to verify... complies with... IEC 60601-1-2."
IV. Home Healthcare Environment Safety	Compliance with IEC 60601-1-11 (Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment).	"Non-clinical testings have been conducted to verify... complies with... IEC 60601-1-11."
V. Laser Safety Classification	Compliance with IEC 60825-1 (Safety of laser products - Part 1: Equipment classification, and requirements) resulting in a Class 3R laser classification.	"Testing to IEC 60825-1 certifies the laser system to classification 3R, which is the same as the predicate device."
VI. Biocompatibility	Compliance with ISO 10993-5 (Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity) and ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization) for all body-contacting materials.	"The device has been tested for biocompatibility, it complies with the following standards: ISO 10993-5 [and] ISO 10993-10."
VII. Software Verification & Validation	Compliance with FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices."	"Software verification and validation test according to the requirements of the FDA 'Guidance for Pre Market Submissions and for Software Contained in Medical Devices.'"
VIII. Lithium Battery Safety	Compliance with IEC 62133 (for lithium battery).	"the lithium battery of the subject device has passed IEC62133 test."
IX. Power Adapter Safety	Assessed for electrical safety along with the main unit.	"the power adapter has been assessed for electrical safety test along with the main unit."

Study Information (Non-Clinical):

Sample Size for Test Set and Data Provenance: Not applicable for clinical efficacy. For non-clinical studies, the "sample size" would refer to the number of devices or components tested. This is not explicitly stated but implied to be sufficient for compliance testing. The provenance is Shenzhen, China (manufacturer location) and third-party labs. All studies are presumably prospective for the purpose of this 510(k) submission.
Number of Experts and Qualifications: Not applicable for establishing "ground truth" for clinical efficacy. Experts would be involved in designing and conducting the non-clinical tests (e.g., electrical engineers, toxicologists), but their specific number and qualifications are not detailed in this summary.
Adjudication Method: Not applicable for clinical efficacy. For non-clinical tests, results are typically assessed against pre-defined thresholds or criteria in the respective standards.
MRMC Comparative Effectiveness Study: Not done.
Standalone Performance (Algorithm): Not applicable; this is a physical LLLT device, not an AI algorithm.
Type of Ground Truth: For the non-clinical studies, the "ground truth" refers to the established technical standards (e.g., IEC, ISO) and the measurable properties of the device (e.g., electrical output, laser wavelength, material cytotoxicity).
Sample Size for Training Set: Not applicable.
How Ground Truth for Training Set was Established: Not applicable.

Conclusion:

The K213447 submission is a premarket notification based on demonstrating "substantial equivalence" of the LLLT Laser Hair Growth Cap to an existing legally marketed device. This pathway generally relies on demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The "studies" referenced are non-clinical bench tests and comparisons against recognized standards to ensure the device's safety and fundamental performance characteristics are equivalent to the predicate. There is no reported clinical study in this document to prove the device meets specific acceptance criteria for hair growth efficacy itself. The efficacy is implicitly accepted based on the predicate device's prior clearance and the similarity of the technology.

Ask a Question

Ask a specific question about this device

Page 1 of 1