Hair Up

K180617 · Y & J Bio Co., Ltd. · OAP · Jun 1, 2018 · Physical Medicine

Device Facts

• Record ID: K180617
• Device Name: Hair Up
• Applicant: Y & J Bio Co., Ltd.
• Product Code: OAP · Physical Medicine
• Decision Date: Jun 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Hair Up 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

Hair Up is a helmet-based device for promoting hair growth; utilizes 21 red visible laser diodes and 30 red light-emitting diodes (LEDs) to provide coverage to the upper scalp. Device operates via low-level light therapy; system includes an outer helmet and protective inner liner. Features automatic therapy pause if head position is incorrect; signals completion of therapy cycle. Intended for home use by patients. Healthcare providers use the device to treat androgenetic alopecia; benefits include potential hair growth stimulation. Device is identical to previously cleared Hair Up (K172968) with updated indications for use.

Clinical Evidence

Bench testing only. Performance data included measurement of wavelength and average output power. Safety and performance evaluated per IEC 60601-1 (basic safety), IEC 60601-1-2 (EMC), IEC 60825-1 (laser safety), and ISO 10993-5/10 (biocompatibility). Risk management followed ISO 14971 and usability followed IEC 62366.

Technological Characteristics

Helmet-based system; 21 red laser diodes (655 nm) and 30 red LEDs. Input: AC 100V-240V, 50/60Hz, 5V 2A. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, ISO 10993-5, ISO 10993-10, ISO 14971, IEC 62366. Class II device.

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.

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 (K140931)

Reference Devices

• iGrow-II Hair Growth System (K141567)
• iHelmet Hair Growth System (K162782)

Submission Summary (Full Text)

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June 1, 2018

Y&J BIO Co, Ltd., Ms. Mina Joo Assistant Manager BT Solutions, Inc. 91-14 Seolleung-ri #402 Gangnam-gu, Seoul, 06150 Kr

Re: K180617

Trade/Device Name: Hair Up Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: March 6, 2018 Received: March 8, 2018

Dear Mina 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, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 comprehensive regulatory information about mediation-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,

# Jennifer R. Stevenson -S3

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) K180617

Device Name Hair Up

#### Indications for Use (Describe)

The Hair Up 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: | 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 402, 91-14 Seolleung-ro, Seoul, Republic of<br>Korea<br>Tel) +82.2.538.9140<br>Email) [e-mail] |
| Preparation Date: | June-1-2018 |
| 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 Primary Predicate device

| Applicant | Device Name | 510(k) Number |
|--------------------|-----------------------------|---------------|
| Apira Science Inc. | iGrow-II Hair Growth System | K140931 |

| Applicant | Device Name | 510(k) Number |
|----------------------------------|-----------------------------|---------------|
| Apira Science Inc. | iGrow-II Hair Growth System | K141567 |
| Slinph Technologies<br>Co., Ltd. | iHelmet Hair Growth System | K162782 |

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#### Hair Up 510(k) Summary

#### 4. Device Description

The Hair Up is basically an identical device with the 510(k)-cleared device Hair Up (K172968). A new 510(k) clearance is applied this time with a new indications for use (IFU).

Subject device, Hair up and its primary predicate device 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 full coverage of the upper 1/3 of the head which is commonly covered with stylized hair. The system will automatically pause therapy until the correct head position is re-established. At the end of the therapy cycle, the subject device Hair Up signals that therapy is complete and the device is ready to be powered down.

#### 5. Indications / Intended Use

The Hair Up 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

| | Primary Predicate Device | Reference Device 1 | Reference Device 2 | Proposed Device |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K140931 | K141567 | K162782 | Not Available |
| Manufacturer | Apira Science, Inc. | Apira Science, Inc. | Slinph Technologies Co., Ltd. | Y&J BIO Co., Ltd. |
| Device Name | iGrow-II Hair Growth System | iGrow-II Hair Growth System | iHelmet Hair Growth System | Hair Up |
| Clearance Date: | December 5, 2014 | August 21, 2014 | April 4, 2017 | N/A |
| Classification / Regulation | Class 2 / 890.5500 | Class 2 / 890.5500 | Class 2 / 890.5500 | Class 2 / 890.5500 |
| Product Code | OAP | OAP | OAP | OAP |
| Intended Use | The iGrow-II Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV. | The iGrow-II Hair Growth System is indicated 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. | iHelmet Hair Growth System (Model: LTD200S) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton | The Hair Up 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 |

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

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#### Hair Up 510(k) Summary

| Mode of Operation | Low-level laser diodes and light emitting diodes | Low-level laser diodes and light emitting diodes | Low-level laser diodes and light emitting diodes | Low-level laser diodes and light emitting diodes |
|-------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Wavelength | 655 nm | 655 nm | $650 nm\pm10 nm$ | 655 nm |
| Electrical 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 | Input: DC 5V, 2A, USB charger;<br>Internal lithium battery<br>Battery Voltage 3.7V<br>Battery Capacity 3000mAh , 11.1Wh | Input: AC 100V ~ 240V (free voltage)<br>Frequency: 50Hz/60Hz<br>Power: 5V 2A |
| How to use | Helmet system | Helmet system | Helmet system | Helmet system |
| Treatment time | 20-25 min | 20-25 min | 20-35 min | 20-25 min |
| | | | Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV. | of I-II and Fitzpatrick Classification of Skin Phototypes I to IV. |

#### Reference Devices: 1. Apira Science, Inc's iGrow-II Hair Growth System (K141567)*

*This reference device is referred, of which the technical aspects such as number of diodes, treatment time and intended use for males are same to those of the Hair Up.

- 2. Slinph Technologies Co., Ltd.'s iHelmet Hair Growth System (K162782) **
**This reference device is referred, of which the intended use for both males and females is same, the fluence and irradiance are comparable to those of the Hair Up.

### 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 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.

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#### Hair Up

#### 510(k) Summary

- Risk management was recorded by referring to ISO 14971:2007. -
- -Usability was documented referring to IEC 62366.

### 7. Conclusions

The technological characteristics of the subject device Hair Up are comparable to those of the predicates for comparable indications for use. Thus, subject device Hair Up is concluded to be substantially equivalent to the predicates.