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

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 280, 272, 147, and 80 laser diodes at 650nm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included battery pack.

AI/ML Overview

The provided text describes the regulatory clearance (K192627) for a medical device called "Laser Hair Growth Cap." This document is a 510(k) Summary, which outlines how the device demonstrates substantial equivalence to previously cleared predicate devices. It focuses heavily on non-clinical testing and comparison of technical specifications rather than extensive clinical studies or AI performance metrics.

Based on the provided text, the device in question (Laser Hair Growth Cap) is a Low Level Laser Therapy (LLLT) device intended to promote hair growth. The document emphasizes substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study involving AI or human reader performance.

Therefore, many of the requested items (acceptance criteria for AI performance, sample sizes for AI test sets, number of experts for ground truth, MRMC studies, standalone AI performance, etc.) are not applicable to this document as it pertains to a physical medical device and its substantial equivalence to other physical devices, not an AI/ML algorithm or its associated performance studies.

Here's how to address the request based on the provided document:

A table of acceptance criteria and the reported device performance:
The document does not present "acceptance criteria" in the traditional sense of performance metrics for an AI/ML device (e.g., sensitivity, specificity, accuracy). Instead, it demonstrates substantial equivalence by comparing technical specifications and safety/performance test results against established standards. The "performance" reported is compliance with these standards and similar specifications to predicate devices.

Acceptance Criterion (Compliance)	Reported Device Performance
Intended Use Equivalence	Matches predicate devices for promoting hair growth in specific alopecia classifications and Fitzpatrick skin types.
Type of Use (OTC) Equivalence	Matches predicate devices.
Type of Light (LLLT, Laser Diodes) Equivalence	Matches predicate devices.
Wavelength (650 nm) Equivalence	Matches predicate devices.
Energy per laser diode (5mW) Equivalence	Matches predicate devices.
Laser Classification (Class 3R) Compliance	Complied with IEC 60825-1:2014, same as predicates.
Treatment time (30 min, 3x/week) Equivalence	Matches predicate devices.
Applicable People/Skin Equivalence	Matches predicate devices (Norwood-Hamilton IIa-V / Ludwig-Savin I-II, Fitzpatrick I-IV).
Design (Cap) Equivalence	Matches predicate devices.
Safety Standards (IEC 60601-1, -11, -2, IEC 62133, IEC 60950-1) Compliance	Complied with all listed standards.
Biocompatibility (ISO 10993-5, -10) Compliance	Complied with listed standards.
Shelf life	Tested (results not detailed but implied to be acceptable for clearance).
Software validation	Tested (results not detailed but implied to be acceptable for clearance).
Usability (IEC 60601-1-6, IEC 62366-1) Complianc	Complied with listed standards.
Conclusion of Substantial Equivalence	Device found substantially equivalent to predicate devices based on non-clinical testing and comparison.

Sample sizes used for the test set and the data provenance:
The document focuses on non-clinical (engineering, safety, performance, biocompatibility) testing of the physical device, not an AI/ML test set. Therefore, there's no "sample size" of a data set in the AI/ML context. The tests were performed on the device prototypes/production samples.
- Data Provenance: Not applicable in the AI/ML sense. The testing was conducted on samples of the physical device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for this device's clearance pertains to compliance with engineering standards (e.g., laser power output, electrical safety, biocompatibility standards, usability standards) rather than clinical ground truth established by experts interpreting medical images/data. The "experts" involved would be engineers and safety/quality assurance professionals verifying compliance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no test set requiring adjudication in the context of AI/ML ground truth establishment.
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 is a physical device (Laser Hair Growth Cap), not an AI-assisted diagnostic or interpretive tool. No MRMC study involving human readers or AI assistance was conducted or mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm; it is a physical laser device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this regulatory submission is compliance with established international and national standards for medical devices, particularly for laser safety, electrical safety, biocompatibility, and general device performance. This is verified through laboratory testing and engineering analysis rather than clinical outcomes or expert consensus for diagnosis. The "intended use" (promoting hair growth) is aligned with the predicate device's intended use which was previously established.
The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
Not applicable. As there is no AI/ML component, there is no training set or a process for establishing its ground truth.

In summary: The provided FDA 510(k) summary (K192627) is for a physical medical device (Laser Hair Growth Cap) that uses Low Level Laser Therapy. The clearance is based on demonstrating substantial equivalence to existing predicate devices through non-clinical testing for safety, performance, and compliance with recognized standards. This document does not describe the evaluation of an Artificial Intelligence/Machine Learning (AI/ML) algorithm, and therefore, many of the questions related to AI/ML study design and performance criteria are not relevant to this specific submission.

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). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.

December 13, 2019

Shang Fa Biotechnology Co. Chung Ju Zhi General Manager B1F., No. 6, Ln. 1, Oingli St., Tucheng Dist., New Taipei City, 23677 TW

Re: K192627

Trade/Device Name: Laser Hair Growth Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: September 18, 2019 Received: September 23, 2019

Dear Chung Ju Zhi:

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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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.

Purva Pandya Acting 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) K192627

Device Name Laser Hair Growth Cap

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Traditional 510(k), K192627 510 (k) Summary

K192627

510(k) SUMMARY

5.1	Type of Submission:	Traditional
5.2	Date of Summary:	12/12/2019
5.3	Submitter:	Shang Fa Biotechnology Co.
	Address:	B1F., No. 6, Ln. 1, Qingli St., Tucheng Dist., New
		Taipei City 23677, Taiwan (R.O.C.)
	Phone:	+886-967-001688
	Contact:	MS. CHUNG JU ZHI
		(info@new-hair.net)

5.4 Identification of the Device:

Proprietary/Trade Name:	Laser Hair Growth Cap
Model Number:	TW280, TW272, TW147, TW08C
Regulation Description:	Infrared lamp
Review Panel:	General & Plastic Surgery
Regulation Number:	890.5500
Device Class:	II
Product Code:	OAP

5.5 Identification of the Predicate Device:

Predicate Device Name:	Diode Laser Cap
Model Number:	COSMO-030, COSMO-020
Manufacturer:	Cosmo Far East Technology Limited
Regulation Number:	890.5500
Device Class:	II
Product Code:	OAP
510(k) Number:	K173678
Predicate Device Name:	Irradiation Aesthetic Device
Model:	HairPro

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Traditional 510(k), K192627 510 (k) Summary

Manufacturer:	Chongqing Peninsula Medical Technology Co., Ltd.
Regulation Number:	890.5500
Device Class:	II
Product Code:	OAP
510(k) Number:	K171835

Intended Use/ Indications for Use of the Device 5.6

Laser Hair Growth 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 Fitzpatrick Skin Phototypes I-IV.

5.7 Device Description

5.8 Substantial Equivalence Determination

Laser Hair Growth Cap (model number: TW280, TW272, TW147, and TW080) submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation and performance to the cleared Diode Laser Cap, model number: COSMO-030 and COSMO-020 (K173678), and Irradiation Aesthetic Device, model: HairPro (K171835). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

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Traditional 510(k), K192627

Item	Subject device	Predicate device I	Predicate device II	Substantialequivalencedetermination
510(k) No.	K192627	K173678	K171835
Proprietaryname	Laser Hair GrowthCap	Diode Laser Cap	Irradiation AestheticDevice	N/A
Model number	TW280, TW272,TW147, TW080	COSMO-030,COSMO-020	HairPro
Intended use	Laser Hair GrowthCap is indicated topromote hair growthin males withandrogenic alopeciawho haveNorwood-Hamiltonclassifications ofIIa-V or females withandrogenic alopeciawho haveLudwig-SavinClassifications of I-IIand both withFitzpatrick SkinPhototypes I-IV.	Diode Laser Cap isindicated to promotehair growth in maleswith androgenicalopecia who haveNorwood-Hamiltonclassifications ofIIa~~V or femaleswith androgenicalopecia who haveLudwig-SavinClassifications ofI~~II and both withFitzpatrick SkinPhototypes I to IV.	The IrradiationAesthetic Device(Model: HairPro) isindicated to promotehair growth infemales withandrogeneticalopecia who haveLudwig-SavinClassifications of I -II and males withandrogeneticalopecia who haveNorwood- HamiltonClassifications ofIIa - V and for both,FitzpatrickClassification ofSkin Phototypes I toIV.	SE
Type of use	OTC	OTC	OTC	SE
Type of light	Low level lasertherapy (LLLT);Laser diodes	Low level lasertherapy (LLLT);Laser diodes	Low level lasertherapy (LLLT);Laser diodes	SE
Item	Subject device	Predicate device I	Predicate device II	Substantialequivalencedetermination
Wavelength	650 nm	650 nm	650 nm	SE
Amount of laserdiodes	TW280: 280TW272: 272TW147: 147TW080: 80	COSMO-030: 272,COSMO-020: 148	81	SE*
*SE determination:Amount of laser diodes of the subject device can be corresponding to that of thepredicate devices. The difference in number of diodes is of no consequence anddoes not affect safety or efficacy as there is a wide range of number of diodes inthe predicate devices listed and in other LLLT devices cleared under productcode OAP. Thus, we consider the subject device is substantially equivalent to thepredicate devices.
Energy of perlaser diode	5mW	5mW	5mW	SE
Classificationaccording toIEC60825-1	Class 3R	Class 3R	Class 3R	SE
Treatment time	Each treatment: 30min;16 weeks, 3 timesper week spaced outevery other day	Each treatment: 30min;16 weeks, everyother day(indefinite)	Each treatment: 30min;Total treatment: 3times per week	SE*
*SE determination:All devices have the same treatment time for 30 mins. The subject devicerecommends the treatment frequency should be 3 times per week spaced outevery other day, and that is equal to the frequency of predicates. LLLT devicecan be used more than 16 weeks under the condition without exceeding everyother day for 30 minutes. Therefore, we consider the subject device issubstantially equivalent to the predicate devices
Item	Subject device	Predicate device I	Predicate device II	Substantialequivalencedetermination
Applicablepeople	Male:Norwood-HamiltonIIa~~VFemale:Ludwig-Savin I~~II	Male:Norwood-HamiltonIIa~~VFemale:Ludwig-Savin I~~II	Male:Norwood-HamiltonIIa~~VFemale:Ludwig-Savin I~~II	SE
Applicable skin	Fitzpatrick SkinPhototypes I-IV	Fitzpatrick SkinPhototypes I-IV	Fitzpatrick SkinPhototypes I-IV	SE
Design	Cap	Cap	Cap	SE
Dimension(LWH)	22189 cm	22189 cm	19.917.98.8 cm	SE*
Weight	TW280: 0.32 kgTW272: 0.30 kgTW147: 0.26 kgTW080: 0.25 kg	0.26 kg	1000g	SE*
Environment foroperation	Temperature:5 °C~~30°C(41°F~~86°F)Humidity: 15%~90%	Temperature:10 °C~~30°C(50°F~~86°F)Humidity: 20%~80%	Temperature:5 °C~30°CHumidity: ≤80%	SE*
Environment forstorage	Temperature:-40 °C~~70°C(-40°F~~158°F)Humidity:10%~100%	Temperature:-10 °C~~60°C(14°F~~140°F)Humidity: 20%~80%	Temperature:0°C~50°CHumidity: ≤ 85%	SE*
*SE determination:The above items, "Dimension", "Weight", "Environment for Operation" and"Environment for Storage" of subject device are slightly different from thepredicate devices, but it will not affect the main function and the intended use ofthe device as they all also comply with IEC 60601-1 requirements Besides the
Item	Subject device	Predicate device I	Predicate device II	Substantialequivalencedetermination
subtle changes of the physical characteristics will not affect the critical functionsor the normal use. Therefore, we consider the subject device is substantiallyequivalent to the predicate devices.
Safety feature	Complied withIEC 60601-1,IEC 60601-1-11,IEC 60601-1-2,IEC 60825-1	Complied withIEC 60601-1,IEC 60601-1-11,IEC 60601-1-2,IEC 60825-1	Complied withIEC 60601-1,IEC 60601-1-11,IEC 60601-1-2,IEC 60825-1	SE
	Complied withIEC 62133 (Batterypack)	Complied withIEC 62133 (Batterypack)
	Complied withIEC 60950-1(Adapter)	Complied withIEC 60950 (Adapter)
Biocompatibilityfeature	Complied with ISO10993-5 and ISO10993-10.	Complied with ISO10993-5 and ISO10993-10.	Complied with ISO10993-5 and ISO10993-10.	SE

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Traditional 510(k), K192627

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રું છે Similarity and Difference

Laser Hair Growth Cap (model number: TW280, TW272, TW147, and TW080) has been compared with "Diode Laser Cap, model number: COSMO-030 and COSMO-020" and "Irradiation Aesthetic Device, model: HairPro".

The safety and performance tests have been conducted on subject device, and the results complied with the test requests. Testing to IEC 60825-1 certifies the laser system to classification 3R, same as the predicates.

The subject device has the same safety and performance claims, principle of

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operation, and similar technological characteristics as the predicate devices. Although there are slight difference on few specifications between the subject device and the predicate devices, after comparison analyzed considering test results, the difference did not raise any problem of substantial equivalence. No new safety or efficacy concerns are raised due to the minor differences present between devices.

5.10 Non-clinical Testing

A series of safety and performance tests were conducted on the subject device, Laser Hair Growth Cap (model number: TW280, TW272, TW147, and TW080).

. Shelf life
Software validation .
. Biocompatibility
- ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
. Electromagnetic compatibility and electrical safety
- IEC 60601-1:2005+COR.1:2006+COR.2:2007+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-11:2015, 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 60601-1-2:2014, Medical electrical equipment Part 1-2: General । requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 62133:2012 (Battery pack), Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements

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for portable sealed secondary cells, and for batteries made from them, for use in portable applications.

IEC 60950-1:2005+A1:2009+A2:2013 (Adapter), Information । technology equipment - Safety - Part 1: General requirements.
Performance test .
- IEC 60825-1:2014, Safety of laser products Part 1: Equipment classification and requirements.
Usability test .
- IEC 60601-1-6:2010+A1:2013, Medical electrical equipment Part 1-6: General requirements forbasic safety and essential performance -Collateral standard: Usability.
- IEC 62366-1:2015, Medical devices Part 1: Application of usability । engineering to medical devices.

All the test results demonstrate Laser Hair Growth Cap (model number: TW280. TW272. TW147. and TW080) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.

5.11 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

5.12 Conclusion

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that Laser Hair Growth Cap (model number: TW280, TW272, TW147, and TW080) is substantially equivalent to the 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.