The easy Hairfull is intended to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification of Skin Phototypes I to IV, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.

Device Description

The easy Hairfull consists of 21 red visible laser diodes (LDs) and 30 red light emitting diodes (LEDs) configured within an outer helmet and protective inner liner. The use of LDs and LEDs provides for a full coverage of the upper 1/3 of the head where commonly covered with stylized hair. The system automatically pauses therapy when the device is not in the correct head position and resumes treatment when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and the device will automatically turn off.

The device could be powered by internal rechargeable li-on battery, and it can also be supplied by specified external adapter with Input AC 100-240V, 50/60Hz and Output DC 5V, 2A.

AI/ML Overview

The easy Hairfull device, an infrared lamp for hair growth, received 510(k) clearance based on its substantial equivalence to a predicate device, Hair Up (K180617). The submission refers to non-clinical tests to demonstrate device performance and safety, but does not include any information regarding a clinical study assessing the device's efficacy in promoting hair growth, nor does it provide specific acceptance criteria or reported device performance metrics related to hair growth from such a study.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, there are no specific performance acceptance criteria or reported device performance results related to hair growth efficacy. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technical characteristics and adherence to safety standards.

The table below summarizes the technical characteristics compared to the predicate device, which implies that matching these characteristics was the "acceptance criteria" for demonstrating substantial equivalence and thus clearance.

Acceptance Criteria (Technical Characteristic)	easy Hairfull Performance (Proposed Device)	Predicate Device (Hair Up, K180617) Performance	Device Meets Acceptance Criteria?
Manufacturer	Y&J BIO Co., Ltd.	Y&J BIO Co., Ltd.	Yes
Device Name	easy Hairfull	Hair Up	N/A (different name)
Classification / Regulation	Class 2 / 890.5500	Class 2 / 890.5500	Yes
Product Code	OAP	OAP	Yes
Intended Use	Promote hair growth in specific androgenetic alopecia classifications (males IIa-V, females I-II) and Fitzpatrick Skin Phototypes I-IV	Promote hair growth in specific androgenetic alopecia classifications (males IIa-V, females I-II) and Fitzpatrick Skin Phototypes I-IV	Yes
Mode of Operation	Low-level laser diodes and light emitting diodes	Low-level laser diodes and light emitting diodes	Yes
Wavelength	655 nm	655 nm	Yes
Number of LDs/LEDs	LDs: 21, LEDs: 30	LDs: 21, LEDs: 30	Yes
Electrical Requirements (Input)	AC 100V ~ 240V, 50Hz/60Hz, 5V 2A	AC 100V ~ 240V, 50Hz/60Hz, 5V 2A	Yes
Battery Type	li-on battery	li-on battery	Yes
How to use	Helmet system	Helmet system	Yes
Treatment time	Each 20-25 min, every two days for 16 weeks	Each 20-25 min, every two days for 16 weeks	Yes
Maximum Power	5mW	5mW	Yes

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe an efficacy clinical study using a test set of human subjects for evaluating hair growth. The "Performance Data" section refers to non-clinical tests regarding wavelength, output power, safety, electromagnetic compatibility, photobiological safety, risk management, and usability, all performed on the device itself, not on human subjects for efficacy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Since no human test set was described for efficacy evaluation, there is no mention of experts establishing ground truth for such a test. The evaluation for market clearance was based on substantial equivalence for technical and safety parameters.

4. Adjudication Method for the Test Set

Not applicable. No human test set for efficacy evaluation was 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 device is not an AI-powered diagnostic or assistive technology for human readers. It's a therapeutic device using light to promote hair growth.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. As mentioned, this is a therapeutic device, not an algorithm, and the provided document does not include a standalone performance study in a clinical context for efficacy. The "Performance Data" section lists non-clinical tests performed on the device in a standalone manner (e.g., measurement of wavelength, power output), but these are not for efficacy.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the safety and technical performance data presented (non-clinical tests), the "ground truth" would be established by physical measurements, engineering standards, and regulatory requirements (e.g., IEC standards, 21 CFR regulations).

For the intended use (promoting hair growth), the document does not present any efficacy data or associated ground truth. The clearance is based on the device being substantially equivalent to a previously cleared device (Hair Up K180617) which presumably had its efficacy established in prior submissions (though details of that are not in this document).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary

{0}------------------------------------------------

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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

December 8, 2020

Y&J BIO Co., Ltd. % Paweena U-Thainual CEO MDR Solutions Co., Ltd 1435 Kanjanapisek Road, Bang Khae Nuea Bangkok, Bang Khae 10160 Thailand

Re: K202983

Trade/Device Name: easy Hairfull Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: September 28, 2020 Received: September 30, 2020

Dear Paweena U-Thainual:

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.

{1}------------------------------------------------

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 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K202983

Device Name easy Hairfull

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

5. 510(k) Summary

1. General Information

Applicant/Submitter:	Y&J BIO Co., Ltd.
Address:	B-916 ,947, Hanam-daero, Hanam-si,Gyeonggi-do, Republic of KoreaTel) +82-31-5180-3491
Contact Person:	Paweena U-Thainual, MDR Solutions Co., Ltd.
Address:	1435 Kanjanapisek Road, Bang Khae Nuea,Bang Khae, Bangkok, THAILAND 10160Tel: +66-2-804-2101Email: paweena@mdrsolutions.co.th
Preparation Date:	September 18, 2020

2. Device Name and Code

Device Trade Name:	easy Hairfull
Common Name:	Lamp, non-heating, for promotion of hair growth
Classification Name:	Infared lamp
Product Code:	OAP
Regulation Number:	890.5500
Classification:	Class II
Review Panel:	General & Plastic Surgery

3. Predicate Devices

Easy Hairfull is substantially equivalent to the following device

	Table 5.1 Predicate devices
--	-----------------------------

Applicant	Device Name	510(k) Number
Y&J BIO Co., Ltd.	Hair Up	K180617

4. Device Description

The easy Hairfull is basically an identical device with the 510(k)-cleared device Hair up (K180617). A new 510(k) clearance is applied this time with the difference in the location of the

{4}------------------------------------------------

easy Hairfull

510(k) Summary

controller and battery. The controller where the battery embedded is located on the headset at this time.

The device could be powered by internal rechargeable li-on battery, and it can also be supplied by specified external adapter with Input AC 100-240V, 50/60Hz and Output DC 5V, 2A.

5. Indications / Intended Use

6. Technical Characteristics in Comparison to Predicate Devices

	Predicate Device	Proposed Device	SE
	510(K)Number	K180617	K202983
Manufacturer	Y&J BIO Co., Ltd.	Y&J BIO Co., Ltd.	YES
Device Name	Hair Up	easy Hairfull

ClearanceDate:	June 1, 2018	N/A

Classification /Regulation	Class 2 / 890.5500	Class 2 / 890.5500	YES

Product Code	OAP	OAP	YES
Intended Use	The Hair Up is intended to promotehair growth in males withandrogenetic alopecia who haveNorwood Hamilton Classifications ofIla to V and Fitzpatrick Classificationof Skin Phototypes I to IV, and infemales with androgenetic alopeciawho have Ludwig-SavinClassifications of I-II and FitzpatrickClassification of Skin Phototypes I toIV.	The easy Hairfull is intended to promotehair growth in males with androgeneticalopecia who have Norwood HamiltonClassifications of IIa to V and FitzpatrickClassification of Skin Phototypes I to IV,and in females with androgeneticalopecia who have Ludwig-SavinClassifications of I-II and FitzpatrickClassification of Skin Phototypes I to IV.	YES
Mode ofOperation	Low-level laser diodes and lightemitting diodes	Low-level laser diodes and light emittingdiodes	YES
Wavelength	655 nm	655 nm	YES

Easy Hairfull is substantially equivalent to the following legally marketed predicate devices.

{5}------------------------------------------------

easy Hairfull 510(k) Summary

Number ofLDs/LEDs	LDs: 21LEDs: 30	LDs: 21LEDs: 30	YES
ElectricalRequirements	Input: AC 100V ~ 240V (free voltage)Frequency: 50Hz/60HzPower: 5V 2A	Input: AC 100V ~ 240V (free voltage)Frequency: 50Hz/60HzPower: 5V 2A	YES
Battery Type	li-on battery	li-on battery	YES
How to use	Helmet system	Helmet system	YES
Treatment time	Each Treatment: 20-25 minTotal Treatment: every two days, for16 weeks	Each Treatment: 20-25 minTotal Treatment: every two days, for 16 weeks	YES
MaximumPower	5mW	5mW	YES

6. Performance Data

Non-clinical tests: Measurement of wavelength and average output power, of treatment were performed. Testing conducted on the easy Hairfull shows that it refers to the relevant mandatory performance standards for laser products 21 CFR 1040.10 and 1040.11. Other performance, such as basic safety, etc, were tested using following consensus standards:

Basic safety and essential performance of the easy Hairfull is tested and evaluated according to IEC 60601-1:2005.
Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard. IEC 60601-1-2:2014.
-Safety of laser products is evaluated according to FDA-recognized consensus standard, IEC 60825-1: 2014.
Photobiological safety of lamps and lamp systems is evaluated according to FDA-recognized consensus standard, IEC 62471:2006.
-Risk management was recorded by referring to ISO 14971:2007.
-Usability was documented referring to IEC 60601-1-6.

7. Substantial Equivalence

The intended use of the easy Hairfull is within the scope of the predicate devices. Easy Hairfull, from both a design and clinical perspective, uses similar or identical technology as the cited predicate devices and has the same intended uses. Based upon the predicted overall performance characteristics for the easy Hairfull, Y&J BIO Co., Ltd. believes that no significant differences exist in usage of its underlying technological principles between easy Hairfull and the cited predicate devices.

8. Conclusions

On the basis of the information provided in this Summary, Y&J BIO Co., Ltd. believes that the easy Hairfull is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.

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.