Laser Cap 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-II and both with Skin Phototypes I-IV.

Device Description

Laser Cap is a hand-held cap-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the cap covers the user's scalp to ensure the laser light reaches the user's scalp. Model Hat-01 contains 82 laser diodes.

AI/ML Overview

The provided text is a 510(k) summary for the "Laser Cap, Model: Hat-01" device. It outlines the regulatory clearance process and compares the device to predicate devices. However, it does not contain information about acceptance criteria for a study proving device performance, nor details of such a study.

The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics and adherence to safety and electromagnetic compatibility (EMC) standards.

Specifically, the "Performance Data" section (numbered VIII) lists biocompatibility testing and electrical and EMC safety testing. These are general compliance tests for medical devices, not a study designed to prove the efficacy of the "Laser Cap" in promoting hair growth against established acceptance criteria.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance: This information is not present.
Sample size used for the test set and data provenance: No efficacy study is described.
Number of experts used to establish ground truth and qualifications: Not applicable, as no clinical efficacy study is detailed.
Adjudication method for the test set: Not applicable.
MRMC comparative effectiveness study details: No such study is mentioned.
Standalone (algorithm-only) performance: This device is a physical laser cap, not an algorithm.
Type of ground truth used: Not applicable, as no clinical efficacy study is detailed.
Sample size for the training set: Not applicable, as this is a physical device, not an AI/ML model being trained.
How ground truth for the training set was established: Not applicable.

The document's purpose is to show that the new device is as safe and effective as existing, cleared devices, primarily through comparison of design, materials, and compliance with general safety standards, rather than presenting a novel clinical efficacy study.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 24, 2023

Hubei YJT Technology Co.,Ltd % Gamma Zhang RA Manager Shenzhen Tacro Medical technology services Co., Ltd. Suite 405, Bldg. A Nanfeng, No.4093 Liuxian Blvd., Nanshan Dist. Shenzhen, Guangdong 510000 China

Re: K232356

Trade/Device Name: Laser Cap, Model: Hat-01 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: August 7, 2023 Received: August 7, 2023

Dear Gamma Zhang:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tanisha L. Hithe Tanisha L. J 2023.10.24 Hithe -S 11:29:35 -04'00' Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232356

Device Name Laser Cap

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

"510(k) Summary" as required by 21 CFR Part 807.92.

Date: 2023-08-07

I. Submitter

Hubei YJT Technology Co.,Ltd. Room1-4, 8F,Block7,Guannan Fuxing Pharmaceutical Park, No.62 Optical Valley Ave, East Lake High-tech Development Zone, Wuhan, Hubei Province, China Tel.: 027-87771565

Jiali Xie (RA engineer) Tel: +86 15327223070 Email: 528149645@gg.com

II. Correspondent Consultant

Shenzhen Tacro Medical technology services Co., Ltd. Suite 405, Bldg. A Nanfeng, No.4093 Liuxian Blvd., Nanshan Dist., Shenzhen, Guangdong

Gamma Zhang (RA manager) Tel: +86 13433933949 Email: wbzhang@tacro.cn

III. Device

Type of 510(k): Traditional Common Name: Laser cap Trade Name: Laser cap Model: Hat-01 Classification Name: Laser, Comb, Hair Regulation Number: 21 CFR 890.5500 Review Panel: Physical Medicine Regulatory Class: II Product Code: OAP

IV. Predicate Device

Applicant	Predicate Device	510(k) Number
Transdermal Cap,Inc.	LaserCap Family of Lasers300, 224, 120 & 80	K203826

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510(k)s –510(k) Summary

Shenzhen CosBeautyTechnology Co., Ltd.	LLLT Laser Hair Growth Cap,Model: Hair Care 88, Hair Care135, Hair Care210	K213447
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V. Device Description

VI. Indications for Use

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VII.Comparison of Technological Characteristics With the Predicate Device

Laser cap raises no safety or efficacy concerns when compared to the predicate devices. A technical comparison to the predicate is provided below:

ComparisonElements	Subject Device	Predicate Device I	Predicate Device II	Comparison
K Number	Pending	K203826	K213447	/
Trade name	Laser Cap	LaserCap Family ofLasers, Models 300,224, 120 and 80	LLLT Laser HairGrowth Cap, Model:Hair Care 88, Hair Care135, Hair Care 210	/
Model	Hat-01	80	Hair Care 88	/
Classificationname	Laser, Comb, Hair	Laser, Comb, Hair	Laser, Comb, Hair	/
Product code	OAP	OAP	OAP	/
Intendeduse/Indicationsfor Use	Laser Cap is indicatedto promote hair growthin males withandrogenic alopeciawho have Norwood-Hamilton classificationsof IIa-V or femaleswith androgenicalopecia who haveLudwig-SavinClassifications of I-IIand both with SkinPhototypes I-IV.	The LaserCap Family ofLasers, models 300, 224,120 and 80 are indicatedto promote hair growthin females withandrogenetic alopeciawho have Ludwig-SavinClassifications of I-II,and males who haveNorwood-HamiltonClassifications of IIa-Vand for both, FitzpatrickSkin Phototypes I to IV.	LLLT Laser HairGrowth Cap is indicatedto promote hair growthin males withandrogenic alopeciawho have Norwood-Hamilton classificationsof IIa-V or females withandrogenic alopeciawho have Ludwig-SavinClassifications of I-IIand both withFitzpatrick SkinPhototypes I-IV.	Same
Location for use	Head	Head	Head	Same
Type of laser	Laser diodes	Laser diodes	Laser diodes	Same
Wavelength	650nm	650nm±5nm	650nm±10nm	Same
Amount of laserdiodes	82	80	88	Same
Energy of perlaser diode	5mW±20%	5mW	5mW ±20%	Same
Classificationaccording to IEC60825-1	Class 3R	Class 3R	Class 3R	Same
Treatment time	16 weeks, for 30-minute treatment times	16 weeks, for 30-minutetreatment times	16 weeks, for 30-minutetreatment times	Same
Treatmentfrequency	3 times per weekspaced out every otherday	3 times per week spacedout every other day	3 times per weekspaced out every otherday	Same
510(k)s =510(k) Summary
ComparisonElements	Subject Device	Predicate Device I	Predicate Device II	Comparison
Applicable people	Norwood-Hamilton IIa~~V(males)Ludwig-Savin I~~II(females)	Norwood-HamiltonIIa~~V (males)Ludwig-Savin I~~II(females)	Norwood-HamiltonIIa~~V (males)Ludwig-Savin I~~II(females)	Same
Applicable skin	Fitzpatrick SkinPhototypes I-IV	Fitzpatrick SkinPhototypes I-IV	Fitzpatrick SkinPhototypes I-IV	Same
Shape design	Helmet	Helmet	Helmet	Same
Safety feature	CompliedwithIEC60601-1,IEC60601-1-11,IEC60601-1-2 andIEC60825-1	Complied withIEC60601-1,IEC60601-1-11, IEC60601-1-2 andIEC60825-1	CompliedwithIEC60601-1,IEC60601-1-11,IEC60601-1-2 andIEC60825-1	Same
Biocompatibility	All body-contactingmaterials arecompliedwithISO10993-5and ISO10993-10,ISO 10993-23.	All body-contactingmaterials arecomplied withISO10993-5and ISO10993-10, ISO10993-23.	All body-contactingmaterials arecomplied withISO10993-5and ISO10993-10,ISO 10993-23.	Same

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VIII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

1) Biocompatibility Testing

The biocompatibility evaluation for the body-contacting components of Laser cap was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recognized by FDA. The testing was performed to, and passed, including:

ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-10:2021, Biological Evaluation of Medical Devices –Part 10: Tests for Skin Sensitization
ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices Part 23: Tests for irritation

2) Electrical and EMC Safety

Electrical safety and EMC safety testing was performed to, and passed, the following standards:

IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
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
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility -Requirements and tests

In addition, testing to IEC 60825-1 certifies the laser system to classification 3R, which is the same as the predicate devices.

Summarv

Based on the above performance as documented in this application, Laser cap was found to have a safety and effectiveness profile that is same as the predicate device.

VIII. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, Laser cap is to be concluded same to its predicate devices.

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.