Hair Up

K172968 · Y & J Bio Co., Ltd. · OAP · Jan 5, 2018 · Physical Medicine

Device Facts

• Record ID: K172968
• Device Name: Hair Up
• Applicant: Y & J Bio Co., Ltd.
• Product Code: OAP · Physical Medicine
• Decision Date: Jan 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.

Device Story

Hair Up is a helmet-based system for home use by patients to promote hair growth. The device 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 system operates via a 20-25 minute therapy cycle. It includes an automatic pause feature if the head position is incorrect and provides a signal upon completion of the therapy cycle. The device is intended for self-administration by the patient.

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 disturbances), IEC 60825-1 (laser safety), and ISO 10993-5/10 (biocompatibility).

Technological Characteristics

Helmet form factor; 21 red laser diodes (LDs) and 30 red light emitting diodes (LEDs); 655 nm wavelength; 5 mW maximum power; AC 100V-240V input; 5V 2A power; IEC 60601-1, IEC 60601-1-2, IEC 60825-1, ISO 10993-5, ISO 10993-10, ISO 14971, and IEC 62366 compliance.

Indications for Use

Indicated for males with androgenetic alopecia, Norwood Hamilton Classifications IIa to V, and Fitzpatrick Skin Phototypes I to IV.

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

• igrow-II Hair Growth System (K141567)

Submission Summary (Full Text)

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January 5, 2018

Y&J BIO Co., Ltd. % Ms. Mina Joo Manager BT Solutions Incorporated Unit 502, 148 Yeoksam-ro Seoul, 06249 Kr

Re: K172968

Trade/Device Name: Hair Up Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: December 6, 2017 Received: December 7, 2017

Dear Ms. Joo:

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. 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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K172968

Device Name Hair Up

Indications for Use (Describe)

Promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification 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: | No. C-413, Munjeong Hyundai Knowledge Center 1,<br>7, Beobwon-ro 11-gil, Songpa-gu, Seoul,<br>Republic of Korea<br>Tel) [phone] | |
| Contact Person: | Mina Joo, BT Solutions, Inc. | |
| Address: | Unit 502, 148 Yuksamro, Gangnam-gu, Seoul,<br>Republic of Korea<br>Tel) +82.2.538.9140<br>Email) [e-mail] | |
| Preparation Date: | September-22-2017 | |

## 2. Device Name and Code

| Device Trade Name: | Hair Up |
|----------------------|-------------------------------------------------|
| 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 (ODE) |

## 3. Predicate Devices

Hair Up is substantially equivalent to the following device

| Table 5.1 Predicate devices | | |
|-----------------------------|-----------------------------|---------------|
| Applicant | Device Name | 510(k) Number |
| Apira Science Inc. | igrow-II Hair Growth System | K141567 |

### 4. Device Description

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#### Hair Up

#### 510(k) Summary

Hair Up shares great similarities with predicate device which is currently market cleared for promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.

Both Hair Up and its predicate device both consist 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 will automatically pause 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.

#### 5. Indications / Intended Use

Promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.

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

| | Predicate Device | Proposed Device |
|------------------|-------------------------------------------|-------------------------------------------|
| 510(K) Number | K141567 | Not Available |
| Manufacturer | Apira Science, Inc. | Y&J BIO Co., Ltd. |
| Device Name | igrow-II Hair Growth System | Hair Up |
| Clearance Date: | | N/A |
| Classification / | Class 2 / 890.5500 | Class 2 / 890.5500 |
| Regulation | | |
| Product Code | OAP | OAP |
| Intended Use | Promotion of hair growth in males with | Promotion of hair growth in males with |
| | androgenetic alopecia who have | androgenetic alopecia who have |
| | Norwood Hamilton Classifications of IIa | Norwood Hamilton Classifications of IIa |
| | to V and Fitzpatrick Classification Skin | to V and Fitzpatrick Classification Skin |
| | Phototypes I to IV. | Phototypes I to IV. |
| Mode of | Low-level laser diodes and light emitting | Low-level laser diodes and light emitting |
| Operation | diodes | diodes |
| Wavelength | 655 nm | 655 nm |
| Electrical | Input: AC 100V ~ 240V (free voltage) | Input: AC 100V ~ 240V (free voltage) |
| Requirements | Frequency: 50Hz/60Hz | Frequency: 50Hz/60Hz |
| | Power: 5V 2A | Power: 5V 2A |
| Maximum Power | 5 mW | 5 mW |
| How to use | Helmet system | Helmet system |
| Treatment time | 20-25 min | 20-25 min |

Hair Up is substantially equivalent to the following legally marketed predicate devices

#### 6. Performance Data

Non-clinical tests: Measurement of wavelength and average output power, of treatment were performed. Testing conducted on the Hair Up shows that it refers to the relevant mandatory

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#### Hair Up

#### 510(k) Summary

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 Hair Up 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.
- Biological evaluation of medical devices is tested and evaluated according to ISO 10993--5: 2009 and ISO 10993-10:2010.
- -Risk management was recorded by referring to ISO 14971:2007.
- Usability was documented referring to IEC 62366. -

#### 7. Substantial Equivalence

The intended use of the Hair Up is within the scope of the predicate devices. Hair Up, from both a design and clinical perspective, uses similar or identical technology as the cited predicate device and has the same intended uses. Based upon the predicted overall performance characteristics for the Hair Up, Y&J BIO Co., Ltd. believes that no significant differences exist in usage of its underlying technological principles between Hair Up 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 Hair Up is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.