The Hair Growth Device is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.

Device Description

The Hair Growth Device LS-D601 is composed of 26 3R class laser diodes (wavelength: 650-660nm, power<5mW) and 30 red light diodes (wavelength: 640nm-660mm) configured within an outer helmet and protective inner liner.

The use of diode lasers and non-laser LEDs provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause to therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.

AI/ML Overview

The provided text does not describe a study that proves the device meets specific acceptance criteria related to its performance in promoting hair growth.

The document is a 510(k) premarket notification for a "Hair Growth Device" (Model LS-D601) and focuses on establishing substantial equivalence to existing predicate devices. It primarily details non-clinical testing for safety and electrical characteristics, along with a usability study, to demonstrate that the device is as safe and effective as previously cleared devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance for hair growth efficacy, nor can I answer questions about sample size for a test set, expert involvement in ground truth establishment, MRMC studies, or standalone algorithm performance, as these relate to a clinical performance study that is not detailed in this document.

Here's what can be extracted from the document regarding the information requested:

1. A table of acceptance criteria and the reported device performance:

This document does not provide acceptance criteria or performance data related to the efficacy of hair growth. The "performance" mentioned refers to non-clinical tests demonstrating safety and electrical conformity.

Acceptance Criteria (Not related to Efficacy)	Reported Device Performance
Biocompatibility:
- In vitro cytotoxicity	Passed
- Skin sensitization	Passed
- Skin irritation	Passed
Electrical Safety & Electromagnetic Compatibility:
- Conformance to ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (General requirements for basic safety and essential performance)	Conformed
- Conformance to IEC 60601-1-2:2014 (EMC)	Conformed
- Conformance to IEC 60601-1-11:2015 (Home healthcare environment)	Conformed
- Conformance to IEC 60601-2-57:2011 (Medical electrical equipment)	Conformed
- Conformance to IEC 60825-1:2007 (Safety of laser products)	Conformed
Software Verification and Validation:
- All software requirement specifications met	Demonstrated that all software requirement specifications are met
- All software hazards mitigated to acceptable risk levels	Demonstrated that all software hazards have been mitigated to acceptable risk levels
Usability:
- Participants able to understand user manual and box labeling	Testing showed participants were able to understand
- Participants able to safely and effectively use the device	Testing showed participants were able to safely and effectively use the device

Questions that cannot be answered from the provided text as they pertain to clinical efficacy studies:

2. Sample size used for the test set and the data provenance: Not applicable, no clinical efficacy test set described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical efficacy test set described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no clinical efficacy test set described.
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 document is for a physical device, not an AI model, and no MRMC study for efficacy is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, no clinical efficacy test set described.
8. The sample size for the training set: Not applicable, no training set for a machine learning model is described for efficacy.
9. How the ground truth for the training set was established: Not applicable, no training set for a machine learning model is described for efficacy.

Summary of what the document does convey about "proving the device meets acceptance criteria":

The document demonstrates that the "Hair Growth Device" meets safety and electrical performance standards, as well as usability requirements, through non-clinical testing. This supports its substantial equivalence to predicate devices, allowing it to be legally marketed. However, it does not provide evidence of new clinical studies to prove its efficacy in promoting hair growth, but rather relies on the established efficacy of the predicate devices based on similar technology and intended use.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 16, 2021

Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. % Jinghua Zhou Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A. No. 62 Nanyun 2nd Road, Science Town Huangpu District, Guangzhou City, Guangdong 510663 China

Re: K210169

Trade/Device Name: Hair Growth Device Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: January 22, 2021 Received: January 22, 2021

Dear Jinghua Zhou:

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 (OS) 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 medical devices and radiation-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 U. Pandya -S

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K210169

Device Name Hair Growth Device

Indications for Use (Describe)

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

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 5 - 510(k) Summary

Date of Summary Preparation: March 31, 2021

1. Submitter's Identifications

Submitter's Name: Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. Address: 401, Building 1, # 3, Xinxing 3rd Road, jiaoshe, Dongkeng Town, Dongguan City, Guangdong Province, China ZIP Code: 523586 Contact Person: Liu Jianwen Contact Title: General Manager Contact E-mail Address: lescolton2012@outlook.com Telephone: +86-755-33141373

2. Correspondent's Identifications

Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town, Huangpu District, Guangzhou City, Guangdong, 510663, China ZIP Code: 510663 Contact Person: Jinghua Zhou Contact Title: Regulation Control Manager Contact E-mail Address: admanzhou@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549

3. Name of the Device

Trade Name: Hair Growth Device Model: LS-D601 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Common Name: Laser, Comb, Hair Regulatory Class: Class II Product Code: OAP Review Panel: General & Plastic Surgery

4. The Predicate Devices

Primary Predicate: K200464 LG Pra.L Derma LD Scalp Care Secondary Predicate: K151662 iRestore Hair Growth System

5. Device Description

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K210169

Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd.

6. Intended Use of Device

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7. Comparison with Predicate Device

Table 1 Technical Characteristic in Comparison to Predicate Devices

	Proposed Device	Primary Predicate	Secondary Predicate
510k number	------	K200464	K151662
Proprietaryname	Hair Growth Device	LG Pra.L Derma LDScalp Care	iRestore Hair GrowthSystem
Model	LS-D601	HGN1	ID-500
Manufacturer	Dongguan LescoltonIntelligent ElectricalAppliance Co., Ltd.	LG Electronics, Inc.	Freedom Laser Therapy,Inc.
Regulationnumber	890.5500	890.5500	890.5500
Regulationname	Infrared Lamp	Infrared Lamp	Infrared Lamp
RegulatoryClass	Class II	Class II	Class II
Product code	OAP	OAP	OAP
Commonname	Laser, Comb, Hair	Lamp, non-heating, forpromotion of hair growth	Lamp, non-heating, forpromotion of hair growth
Review panel	General & PlasticSurgery	General & PlasticSurgery	General & PlasticSurgery
Indicationsfor use	The Hair Growth Deviceis indicated to promotehair growth in males withandrogenetic alopeciawho haveHamilton-NorwoodClassifications of IIa-Vand females withandrogenetic alopeciawho have Ludwig-SavinClassifications of I-II andFitzpatrick Classificationof Skin Phototypes I toIV.	The LG Pra.L Derma LDScalp Care is indicated topromote hair growth inmales with androgeneticalopecia who haveHamilton-NorwoodClassifications of IIa-Vand females withandrogenetic alopeciawho have Ludwig-SavinClassifications of I-II andFitzpatrick Classificationof Skin Phototypes I toIV.	The iRestore HairGrowth System isindicated to promote hairgrowth in females withandrogenetic alopeciawho have Ludwig-SavinClassifications of I - II,males who haveNorwood-HamiltonClassifications of IIa - Vand for both, FitzpatrickClassification of SkinPhototypes I to IV.
Intendeduser	Females & Males	Both sex	Females & Males
Type of use	OTC	OTC	OTC
Mode ofoperation	Low-level laser diodesand light emitting diodes	Low-level laser diodesand light emitting diodes	LLLT Device Type
Wavelength1	Laser: 650-660nmRed light640-660nm	LD: 650~~667nmLED: 645nm~~665nm	—
No. of lightsource2	Laser diodes: 26LED diodes: 30	250	21 red visible light diodelasers30 red lightsuper-luminescent diodes
Power output	<5mW per light outputpoint	5mW per light outputpoint	—
Treatmentduration	25 minutes every otherday for 16 weeks	—	25 minutes every otherday for 16 weeks
Way to getpower	Power adapter	Rechargeable battery	—
Bluetooth3	No	Yes	—

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Note 1: The wavelengths are all within the range of red light wavelengths. The proposed device emits wavelengths that are similar to predicate device. Differences between the devices do not raise new questions regarding the safety and effectiveness of proposed device and the performance testing done demonstrates that the proposed device can be used safety and effectively.

Note 2: Number of light source of proposed device is less than that of primary predicate K200464, close to secondary predicate K151662. Differences between the devices do not raise new questions regarding the safety and effectiveness of proposed device and the performance testing done demonstrates that the proposed device can be used safety and effectively.

Note 3: The proposed device does not have bluetooth capability. This difference between the devices does not raise new questions regarding the safety and effectiveness of proposed device.

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8. Non-Clinical Tests Performed:

The following non-clinical testing was provided in this 510(k):

Biocompatibility Testing - The skin contacting materials of the device were subjected to biocompatibility testing per ISO 10993-1:2018, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" for devices in contact with intact skin, including in vitro cytotoxicity, skin sensitization, and skin irritation. All tests passed. The tests conform with the applicable requirements of the following standards:

ISO10993-5:2009, Biological evaluation of medical devices-Part 5: tests for in vitro cytotoxicity.

ISO10993-10:2010, Biological evaluation of medical devices-Part 10: tests for irritation and skin sensitization.

Electrical Safety and Electromagnetic Compatibility Testing - The Hair Growth Device LS-D601 has been tested and conformed with the applicable requirements of the following standards for medical devices used in the home environment:

• ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance

· 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 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 60601-2-57:2011 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests

· IEC 60825-1:2007 Safety of laser products - Part 1: Equipment classification, and requirements

Software Verification and Validation - Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.

9. Usability Study:

Testing of 15 participants was conducted showing that the participants were able to understand the user manual and box labeling and were able to safely and effectively use the device.

10. Conclusion:

The proposed device uses similar or identical technology as the predicate devices and has the same intended use. Based upon the overall performance characteristics for Hair Growth Device LS-D601, Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. believes that the technological characteristics of Hair Growth Device LS-D601 does not raise new types of questions regarding its safety and efficacy for its intended use compared with the predicate devices. On the basis of the information provided in this 510(k), Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. believes that the Hair Growth Device LS-D601 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.