iHelmet Hair Growth System

K162782 · Slinph Technologies Co., Ltd. · OAP · Apr 4, 2017 · Physical Medicine

Device Facts

• Record ID: K162782
• Device Name: iHelmet Hair Growth System
• Applicant: Slinph Technologies Co., Ltd.
• Product Code: OAP · Physical Medicine
• Decision Date: Apr 4, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

iHelmet Hair Growth System, Model: LTD200S is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ila-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

Device Story

iHelmet Hair Growth System is a wearable helmet device containing 200 laser diodes for treating androgenetic alopecia. Device uses diode lasers (650nm) to provide full scalp coverage without manual movement. Integrated sensors detect head proximity; device pauses treatment if head is not in close proximity and resumes when detected. Audible tone signals treatment completion, followed by automatic shut-off. Intended for home use by patients. Healthcare providers use the device to promote hair growth; output is non-ionizing laser light. Benefits include non-invasive hair growth stimulation. Operational context is home-based; patient self-operates.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance verified via IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60825-1 (laser safety), IEC 60601-1-11 (home use), and ISO 10993-5/10 (biocompatibility). Temperature testing confirmed scalp contact temperature does not exceed 43°C.

Technological Characteristics

Infrared lamp (21 CFR 890.5500). 200 laser diodes (650nm ±10nm). Class 3R laser. Power: 4-5mW per diode. Irradiance: 2.3533 mW/cm2. Fluence: 4.9420 J/cm2. Dimensions: 266mm x 196mm x 135mm. Weight: 600g. Biocompatible materials per ISO 10993. Powered by internal electronics with proximity sensor feedback loop.

Indications for Use

Indicated for females with androgenetic alopecia (Ludwig-Savin I-II) and males with androgenetic alopecia (Norwood-Hamilton IIa-V), 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

• Capillus272 (K153618)
• Capillus202 (K160285)
• Capillus82 (K163170)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 4, 2017

Slinph Technologies Co., Ltd % Cecilia Ceng Manager Guangzhou Glomed Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, 510663 CN

Re: K162782

Trade/Device Name: Ihelmet Hair Growth System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: March 6, 2017 Received: March 9, 2017

Dear Cecilia Ceng:

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. Iisting 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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Jennifer R. Stevenson -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) K162782

Device Name

iHelmet Hair Growth System (Model: LTD200S)

Indications for Use (Describe)

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 Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - 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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### Chapter 6. 510(k) Summary

# 510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 890.5500.

#### 1. Submitter Information

Sponsor Name: Slinph Technologies Co., Ltd. Address: Room 211, Building B, 1970 Cultural and Creative Industrial Park, Minzhi Street, Longhua, Shenzhen, China. Contact name: Zou Jian (General Manager) Tel: [phone] Fax: [phone] Email: [e-mail]

### Application Correspondent:

Contact Person: Ms. Cecilia Ceng Guangzhou GLOMED Biological Technology Co., Ltd. Tel: [phone] Email: [e-mail]

#### 2. Subject Device Information

| Type of 510(k): | Traditional |
|----------------------|-------------------------------------------------|
| Common Name: | Lamp, non-heating, for promotion of hair growth |
| Trade Name: | iHelmet Hair Growth System |
| Classification Name: | Infrared lamp per 21 CFR 890.5500 |
| Review Panel: | General & Plastic Surgery |
| Product Code: | OAP |
| Regulation Number: | 21 CFR 890.5500 |
| Regulation Class: | 2 |

#### 3. Predicate Device Information

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Sponsor: Slinph Technologies Co., LTD Subject Device: iHelmet Hair Growth System, Model: LTD200S File No.: 510(k) submission report (V1.0), Chapter 6

| Sponsor | Capillus, LLC. |
|---------------------|-------------------------------------------------|
| Common Name | Lamp, non-heating, for promotion of hair growth |
| Trade Name | Capillus272, Capillus202, Capillus82 |
| Classification Name | Infrared lamp per 21 CFR 890.5500 |
| 510(k) number | K153618, K160285, K163170 |
| Review Panel | General & Plastic Surgery |
| Product Code | OAP |
| Regulation Number | 21 CFR 890.5500 |
| Regulation Class | 2 |

#### 4. Device Description

iHelmet Hair Growth System consists of laser diodes that are spread throughout the helmet. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. The product will pause automatically treatment if the sensor detects that the head is not in close proximity to the sensor, and will resume again once close enough. At the end of the treatment, an audible tone beeps to indicate the treatment is over and then the helmet automatically shut off.

#### 5. Intended Use

iHelmet Hair Growth System, Model: LTD200S is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ila-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

#### Test Summary 6.

iHelmet Hair Growth System has been evaluated the safety and performance by lab bench testing according to the following standards:

| Standards No. | Standard Title | Version | Date |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|------------|
| IEC 60601-1 | Medical Electrical Equipment - Part 1:<br>General Requirements for Safety | 2005+A1:2012 | 01/14/2014 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2:<br>General requirements for basic safety<br>and essential performance - Collateral<br>standard: Electromagnetic<br>compatibility - Requirements and tests | 2001+A1:2006 | 09/09/2008 |
| IEC 60825-1 | Safety of laser products - Part 1:<br>Equipment classification and<br>requirements | 2007 | 03/2007 |
| IEC60601-1-11 | Medical Electrical Equipment - Part 1- | 2010 | 03/1/2011 |

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| | 11: General Requirements for Basic<br>Safety and Essential Performance -<br>Collateral Standard: Requirements for<br>Medical Electrical Equipment and<br>Medical Electrical Systems Used | | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------------|
| ISO 10993-5<br>(Cytotoxicity) | Biological evaluation of medical<br>devices - Part 5: Tests for In Vitro<br>cytotoxicity | 2009 | 05/05/2010 |
| ISO 10993-10<br>(Sensitization and<br>Irritation) | Biological evaluation of medical<br>devices - Part 10: Tests for irritation<br>and skin sensitization | 2010 | 03/16/2010 |

Except for the tests mentioned above, we have conducted the temperature test on the iHelmet Hair Growth System to prove that the highest temperature between iHelmet Hair Growth System and scalp would not exceed 43°C during operation, which is meet the requirement of safety standard IEC 60601-1.

#### 7. Comparison to Predicate Device

Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.

| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Company | Slinph Technologies Co., Ltd. | Capillus LLC | -- |
| Trade Name | iHelmet Hair Growth System | Capillus272, Capillus202,<br>Capillus82 | -- |
| Classification<br>Name | Infrared Lamp | Infrared Lamp | -- |
| 510(k) Number | K162782 | K153618, K160285, K163170 | -- |
| Product Code | OAP | OAP | SE |
| Intended Use /<br>Indications for<br>Use | iHelmet Hair Growth System<br>(Model: LTD200S) is<br>indicated to promote hair<br>growth in females with<br>androgenetic alopecia who<br>have Ludwig-Savin<br>Classifications I - II, in males<br>with androgenetic alopecia<br>who have Norwood Hamilton<br>Classifications Ila - V and for<br>both, Fitzpatrick<br>Classification of Skin<br>Phototypes of I - IV. | The Capillus272, Capillus202,<br>Capillus82 are intended to treat<br>Androgenetic Alopecia and<br>promote hair growth in males<br>who have Norwood Hamilton<br>Classifications of Ila to V<br>patterns of hair loss and to<br>treat Androgenetic Alopecia<br>and promote hair growth in<br>females who have Ludwig<br>(Savin) Scale I-1 to I-4, II-1, II-<br>2, or frontal; both with<br>Fitzpatrick Skin Types I to IV. | SE |
| Waveform | Visible red laser | Visible red laser | SE |
| Wavelength | 650nm±10nm | 650nm | SE |
| Amounts of | 200 | Capillus272: 272 | SE |

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Sponsor: Slinph Technologies Co., LTD Subject Device: iHelmet Hair Growth System, Model: LTD200S

| Elements of<br>Comparison | Subject Device | Predicate Device | Verdic |
|----------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------|
| Laser Lamp | | Capillus202: 202<br>Capillus82: 82 | Note 1 |
| Energy of per<br>Laser Lamp | 4~5mW | <5mW | SE |
| Classification<br>according to<br>IEC60825-1 | Class 3R | Class 3R | SE |
| Treatment Time | Each Treatment: 20-35 min<br>Total Treatment: every other<br>day, for 16 weeks | Each Treatment: 30 min<br>Total Treatment: every other<br>day, for 17 weeks. | SE<br>Note 1 |
| Treatment Area | 424.93 cm2<br>Mathematically Max. derived | Capillus272: 495.37 cm2<br>Capillus202: 449.51 cm2<br>Capillus82: 194.42 cm2<br>Mathematically Max. derived | SE<br>Note 1 |
| Irradiance<br>(power per area) | 2.3533 mW/cm2<br>Mathematically Max. derived | Capillus272: 2.7454 mW/cm2<br>Capillus202: 2.2469 mW/cm2<br>Capillus82: 2.1088 mW/cm2<br>Mathematically Max. derived | SE<br>Note 1 |
| Fluence | 4.9420 J/cm2<br>Mathematically Max. derived | Capillus272: 4.9417 J/cm2<br>Capillus202: 4.044 J/cm2<br>Capillus82: 3.7920 J/cm2<br>Mathematically Max. derived | SE<br>Note 1 |
| Dimension | 266mm x 196mm x 135mm<br>(L x W x H) | -- | SE<br>Note 2 |
| Weight | 600g | -- | SE<br>Note 2 |
| Environment for<br>Operation | Temperature: 15~30°C<br>Humidity: 30~80% RH<br>Atmosphere range:<br>90~110kPa | -- | SE<br>Note 2 |

dict te 1

SE

SE

SE

Note 2

510(k) submission report (V1.0), Chapter 6 File No.:

Humidity: 0~ 80% RH

Complied with IEC 60601-1

materials are complied with

ISO 10993-5, ISO 10993-10

Atmosphere range:

and IEC 60601-1-2

All patient contacting

50~110kPa

### Comparison in Detail(s):

Environment for

Safety Feature

Biocompatibility

Storage

Feature

### Note 1:

Although the "Amounts of Laser Lamp", "Treatment Time", "Treatment Area", "Irradiance", and "Fluence" of subject device and predicate device are a little difference, the energy and power parameters' range of subject device can be covered by predicate device's several models' range; they are very similar. So these parameters' differences will not raise any safety or effectiveness issue.

--

Complied with IEC 60601-1

All patient contacting materials

are complied with ISO 10993-

and IEC 60601-1-2

5, ISO 10993-10

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### Note 2:

Although the "Weight", "Dimensions", "Environment for Operation", "Environment for Storage" of subject device are different from the predicate device, it will not affect the main function and the intended use of the device as they all also comply with IEC 60601-1 requirements. Besides, the subtle changes of the physical characteristics will not affect the critical functions or the normal use.

### 8. Conclusion

The subject device iHelmet Hair Growth System has all features of the predicate devices. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate devices.

### 9. Summary Prepared Date

2 April 2017