easy Hairfull

K202983 · Y & J Bio Co., Ltd. · OAP · Dec 8, 2020 · Physical Medicine

Device Facts

• Record ID: K202983
• Device Name: easy Hairfull
• Applicant: Y & J Bio Co., Ltd.
• Product Code: OAP · Physical Medicine
• Decision Date: Dec 8, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

Easy Hairfull is a helmet-based device for home use by patients to promote hair growth. It utilizes 21 red visible laser diodes (LDs) and 30 red light-emitting diodes (LEDs) at a 655 nm wavelength to provide coverage to the upper 1/3 of the head. The device operates via an internal rechargeable li-ion battery or an external AC adapter. It features an automated therapy cycle (20-25 minutes) with a position-sensing mechanism that pauses treatment if the device is not correctly positioned on the head and resumes when corrected. The system signals the end of the therapy cycle and automatically powers off. The device is substantially equivalent to the Hair Up (K180617), with the primary design change being the relocation of the controller and battery to the headset.

Clinical Evidence

Bench testing only. Performance data included measurement of wavelength and average output power. Safety and performance were evaluated against IEC 60601-1 (basic safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60825-1 (laser safety), IEC 62471 (photobiological safety), ISO 14971 (risk management), and IEC 60601-1-6 (usability).

Technological Characteristics

Helmet-based phototherapy device; 21 red laser diodes (LDs) and 30 red light-emitting diodes (LEDs); 655 nm wavelength; 5mW max power. Powered by internal li-ion battery or external AC adapter (100-240V, 50/60Hz). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 62471, ISO 14971, IEC 60601-1-6. Connectivity: None.

Indications for Use

Indicated for males with androgenetic alopecia (Norwood Hamilton IIa-V) and females with androgenetic alopecia (Ludwig-Savin I-II), all with Fitzpatrick Skin Phototypes I-IV, to promote hair growth.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Hair Up (K180617)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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) K202983

Device Name easy Hairfull

Indications for Use (Describe)

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.

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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# 5. 510(k) Summary

### 1. General Information

| Applicant/Submitter: | Y&J BIO Co., Ltd. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | B-916 ,947, Hanam-daero, Hanam-si,<br>Gyeonggi-do, Republic of Korea<br>Tel) [phone] |
| Contact Person: | Paweena U-Thainual, MDR Solutions Co., Ltd. |
| Address: | 1435 Kanjanapisek Road, Bang Khae Nuea,<br>Bang Khae, Bangkok, THAILAND 10160<br>Tel: [phone]<br>Email: [e-mail] |
| 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

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## easy Hairfull

#### 510(k) Summary

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

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.

### 5. Indications / Intended Use

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.

### 6. Technical Characteristics in Comparison to Predicate Devices

| | Predicate Device | Proposed Device | SE |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | 510(K)<br>Number | K180617 | K202983 |
| Manufacturer | Y&J BIO Co., Ltd. | Y&J BIO Co., Ltd. | YES |
| Device Name | Hair Up | easy Hairfull | |
| | | | |
| Clearance<br>Date: | June 1, 2018 | N/A | |
| | | | |
| Classification /<br>Regulation | Class 2 / 890.5500 | Class 2 / 890.5500 | YES |
| | | | |
| Product Code | OAP | OAP | YES |
| Intended Use | The Hair Up is intended to promote<br>hair growth in males with<br>androgenetic alopecia who have<br>Norwood Hamilton Classifications of<br>Ila to V and Fitzpatrick Classification<br>of Skin Phototypes I to IV, and in<br>females with androgenetic alopecia<br>who have Ludwig-Savin<br>Classifications of I-II and Fitzpatrick<br>Classification of Skin Phototypes I to<br>IV. | The easy Hairfull is intended to promote<br>hair growth in males with androgenetic<br>alopecia who have Norwood Hamilton<br>Classifications of IIa to V and Fitzpatrick<br>Classification of Skin Phototypes I to IV,<br>and in females with androgenetic<br>alopecia who have Ludwig-Savin<br>Classifications of I-II and Fitzpatrick<br>Classification of Skin Phototypes I to IV. | YES |
| Mode of<br>Operation | Low-level laser diodes and light<br>emitting diodes | Low-level laser diodes and light emitting<br>diodes | YES |
| Wavelength | 655 nm | 655 nm | YES |

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

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#### easy Hairfull 510(k) Summary

| Number of<br>LDs/LEDs | LDs: 21<br>LEDs: 30 | LDs: 21<br>LEDs: 30 | YES |
|----------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----|
| Electrical<br>Requirements | Input: AC 100V ~ 240V (free voltage)<br>Frequency: 50Hz/60Hz<br>Power: 5V 2A | Input: AC 100V ~ 240V (free voltage)<br>Frequency: 50Hz/60Hz<br>Power: 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 min<br>Total Treatment: every two days, for<br>16 weeks | Each Treatment: 20-25 min<br>Total Treatment: every two days, for 16 weeks | YES |
| Maximum<br>Power | 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.