iHelmet Hair Growth System

K190467 · Slinph Technologies Co., Ltd. · OAP · Dec 26, 2019 · Physical Medicine

Device Facts

• Record ID: K190467
• Device Name: iHelmet Hair Growth System
• Applicant: Slinph Technologies Co., Ltd.
• Product Code: OAP · Physical Medicine
• Decision Date: Dec 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

iHelmet Hair Growth System (Model: LTD88Lite, LTD36Air, LTD160Pro) 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 uses diode lasers to promote hair growth; device worn as helmet; laser diodes cover scalp area; no manual movement required. Features proximity sensor; pauses treatment if head not in close proximity; resumes when close. Audible tone signals end of treatment; automatic shut-off. Intended for over-the-counter use. Benefits patient by stimulating hair growth in androgenetic alopecia. Healthcare provider/patient uses device as home-based treatment.

Clinical Evidence

Bench testing only. Evaluated for electrical safety (IEC 60601-1, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), and biocompatibility (ISO 10993-5, ISO 10993-10). Temperature testing confirmed scalp contact temperature does not exceed 43°C.

Technological Characteristics

Infrared lamp (non-heating) for hair growth. Emits visible red laser (650nm ±10nm). Laser diode counts: 36, 88, or 160 depending on model. Power: 4-5mW per diode. Class 3R laser. Patient-contacting materials biocompatibility tested per ISO 10993. Safety features include proximity sensor and automatic shut-off. Operates at 15-30°C.

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

• iHelmet Hair Growth System (K162782)
• Capillus272, Capillus202, Capillus82 (K153618, K160285, K163170)

Submission Summary (Full Text)

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December 23, 2019

Slinph Technologies Co., LTD % S K Manager SK Medical Device International Corp. Suite 52, Floor 16, No. 119 Xing Guang Ying Jing, Shui Ying Road Guangzhou, 51006 CN

Re: K190467

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: November 21, 2019 Received: November 25, 2019

Dear S K:

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.

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

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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 (QS) 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,

Jessica Mavadia-Shukla 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) K190467

### Device Name

iHelmet Hair Growth System, Model: LTD88Lite, LTD36Air, LTD160Pro

Indications for Use (Describe)

iHelmet Hair Growth System (LTD88Lite, LTD36Air, LTD160Pro) 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.

| 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. SK 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 |

#### Predicate Device Information 3.

Predicate device 1

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Sponsor: Slinph Technologies Co., LTD Subject Device: iHelmet Hair Growth System, Model: LTD88Lite, LTD 36Air, LTD160Pro File No.: 510(k) submission report (V1.0), Chapter 6

| Sponsor | iHelmet Hair Growth System |
|---------------------|-------------------------------------------------|
| Common Name | Lamp, non-heating, for promotion of hair growth |
| Trade Name | LTD200S |
| Classification Name | Infrared lamp per 21 CFR 890.5500 |
| 510(k) number | K162782 |
| Review Panel | General & Plastic Surgery |
| Product Code | OAP |
| Regulation Number | 21 CFR 890.5500 |
| Regulation Class | 2 |

| | Predicate device 2 |
|---------------------|-------------------------------------------------|
| 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 |

#### Device Description 4.

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: LTD88Lite, LTD36Air, LTD160Pro) 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.

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#### 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 | 07/09/2014 |
| 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 | Edition 4.0 2014-<br>02 | 06/27/2016 |
| IEC 60825-1 | Safety of laser products - Part 1:<br>Equipment classification and<br>requirements | 2007-03 | 07/09/2014 |
| IEC60601-1-11 | Medical Electrical Equipment - Part 1-<br>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 | 2010 | 06/27/2016 |
| ISO 10993-5<br>(Cytotoxicity) | Biological evaluation of medical<br>devices - Part 5: Tests for In Vitro<br>cytotoxicity | 2009 | 12/23/2016 |
| ISO 10993-10<br>(Sensitization and<br>Irritation) | Biological evaluation of medical<br>devices - Part 10: Tests for irritation<br>and skin sensitization | 2010 | 07/26/2016 |

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 1 | Predicate Device 2 | Verdict |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Company | Slinph Technologies<br>Co., Ltd. | Slinph Technologies<br>Co., Ltd. | Capillus LLC | -- |
| Trade Name | iHelmet Hair Growth<br>System | iHelmet Hair Growth<br>System | Capillus272,<br>Capillus202,<br>Capillus82 | -- |
| Classification<br>Name | Infrared Lamp | Infrared Lamp | Infrared Lamp | -- |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device<br>2 | Verdict |
| 510(k) Number | Applying | K162782 | K153618,<br>K160285, K163170 | -- |
| Product Code | OAP | OAP | OAP | SE |
| Intended Use /<br>Indications for<br>Use | iHelmet Hair Growth<br>System (Model:<br>LTD88Lite,<br>LTD36Air,<br>LTD160Pro) is<br>indicated to promote<br>hair growth in<br>females with<br>androgenetic<br>alopecia who have<br>Ludwig-Savin<br>Classifications I - II,<br>in males with<br>androgenetic<br>alopecia who have<br>Norwood Hamilton<br>Classifications Ila - V<br>and for both,<br>Fitzpatrick<br>Classification of Skin<br>Phototypes of I - IV. | iHelmet Hair Growth<br>System (Model:<br>LTD200S) is<br>indicated to<br>promote hair growth<br>in females with<br>androgenetic<br>alopecia who have<br>Ludwig-Savin<br>Classifications I - II,<br>in males with<br>androgenetic<br>alopecia who have<br>Norwood Hamilton<br>Classifications Ila -<br>V and for both,<br>Fitzpatrick<br>Classification of<br>Skin Phototypes of I<br>- IV. | The Capillus272,<br>Capillus202,<br>Capillus82 are<br>intended to treat<br>Androgenetic<br>Alopecia and<br>promote hair<br>growth in males<br>who have Norwood<br>Hamilton<br>Classifications of<br>Ila to V patterns of<br>hair loss and to<br>treat Androgenetic<br>Alopecia and<br>promote hair<br>growth in females<br>who have Ludwig<br>(Savin) Scale I-1 to<br>1-4, II-1, II-2, or<br>frontal; both with<br>Fitzpatrick Skin<br>Types I to IV. | SE |
| Waveform | Visible red laser | Visible red laser | Visible red laser | SE |
| Wavelength | 650nm±10nm | 650nm±10nm | 650nm | SE |
| Amounts of Laser<br>Lamp | LTD88Lite: 88<br>LTD36Air: 36<br>LTD160Pro: 160 | 200 | Capillus272: 272<br>Capillus202: 202<br>Capillus82: 82 | SE<br>Note 1 |
| Energy of per<br>Laser Lamp | 4~5mW | 4~5mW | <5mW | SE |
| Classification<br>according to<br>IEC60825-1 | Class 3R | Class 3R | Class 3R | SE |
| Treatment Time | Each Treatment: 20-<br>35 min<br>Total Treatment:<br>every other day, for<br>16 weeks | Each Treatment:<br>20-35 min<br>Total Treatment:<br>every other day, for<br>16 weeks | Each Treatment: 30<br>min<br>Total Treatment:<br>every other day, for<br>17 weeks. | SE<br>Note 1 |
| Treatment Area | LTD88Lite: 220.61<br>cm²<br>LTD36Air: 86.3 cm²<br>LTD160Pro: 338.42<br>cm²<br>Mathematically Max.<br>derived | 424.93 cm²<br>Mathematically<br>Max. derived | Capillus272:<br>495.37 cm²<br>Capillus202:<br>449.51 cm²<br>Capillus82: 194.42<br>cm²<br>Mathematically<br>Max. derived | SE<br>Note 1 |

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Sponsor: Slinph Technologies Co., LTD Subject Device: iHelmet Hair Growth System, Model: LTD88Lite, LTD 36Air, LTD160Pro File No.: 510(k) submission report (V1.0), Chapter 6

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| Sponsor: | Slinph Technologies Co., LTD |
|-----------------|--------------------------------------------------------------------|
| Subject Device: | iHelmet Hair Growth System, Model: LTD88Lite, LTD 36Air, LTD160Pro |
| File No.: | 510(k) submission report (V1.0), Chapter 6 |

| Elements of<br>Comparison<br>(per area) | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------|
| | mW/cm²<br>LTD36Air: 2.0857 mW/cm²<br>LTD160Pro: 2.3639 mW/cm²<br>Mathematically Max. derived | Mathematically Max. derived | 2.7454 mW/cm²<br>Capillus202: 2.2469 mW/cm²<br>Capillus82: 2.1088 mW/cm²<br>Mathematically Max. derived | Note 1 |
| Fluence | LTD88Lite: 4.1883 J/cm²<br>LTD36Air: 4.3801 J/cm²<br>LTD160Pro: 4.9642 J/cm²<br>Mathematically Max. derived | 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) | 266mm x 196mm x 135mm<br>(L x W x H) | -- | SE<br>Note 2 |
| Weight | LTD88Lite: about 550g<br>LTD36Air: about 500g<br>LTD36Air: about 600g | 600g | -- | SE<br>Note 2 |
| Environment for<br>Operation | Temperature: 15~30°C<br>Humidity: 30~80% RH<br>Atmosphere range: 90~110kPa | Temperature: 15~30°C<br>Humidity: 30~80% RH<br>Atmosphere range: 90~110kPa | -- | SE<br>Note 2 |
| Environment for<br>Storage | Temperature: - 20~65°C<br>Humidity: 0~ 80% RH<br>Atmosphere range: 50~110kPa | Temperature: - 20~65°C<br>Humidity: 0~ 80% RH<br>Atmosphere range: 50~110kPa | -- | SE<br>Note 2 |
| Safety Feature | Complied with IEC 60601-1 and IEC 60601-1-2 | Complied with IEC 60601-1 and IEC 60601-1-2 | Complied with IEC 60601-1 and IEC 60601-1-2 | SE |
| Biocompatibility<br>Feature | All patient contacting<br>materials are<br>complied with ISO<br>10993-5, ISO 10993-10 | All patient<br>contacting materials<br>are complied with<br>ISO 10993-5, ISO<br>10993-10 | All patient<br>contacting<br>materials are<br>complied with ISO<br>10993-5, ISO<br>10993-10 | SE |

# Comparison in Detail(s):

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

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| Sponsor: | Slinph Technologies Co., LTD |
|-----------------|--------------------------------------------------------------------|
| Subject Device: | iHelmet Hair Growth System, Model: LTD88Lite, LTD 36Air, LTD160Pro |
| File No.: | 510(k) submission report (V1.0), Chapter 6 |

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.

# 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 19 February 2019