Irradiation Aesthetic Device

K171835 · Chongqing Peninsula Medical Technology Co., Ltd. · OAP · Jan 30, 2018 · Physical Medicine

Device Facts

• Record ID: K171835
• Device Name: Irradiation Aesthetic Device
• Applicant: Chongqing Peninsula Medical Technology Co., Ltd.
• Product Code: OAP · Physical Medicine
• Decision Date: Jan 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Irradiation Aesthetic Device (Model: HairPro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

Device Story

Irradiation Aesthetic Device (HairPro) is a wearable cap containing 81 laser diodes (650nm) for treating androgenetic alopecia. Device covers entire scalp; eliminates need for manual movement. Operation: user wears cap; device emits visible red laser light. Features: built-in timer (30-minute treatment duration); automatic shut-off; IR sensor detects if cap is worn, suspending laser output if removed. Used in home setting by patient. Output: low-level laser therapy (LLLT) to scalp. Benefit: promotes hair growth. Healthcare provider uses device output to support treatment of hair loss conditions.

Clinical Evidence

Bench testing only. Device evaluated for safety and performance per IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60825-1 (laser safety), IEC 60601-1-11 (home use), ISO 10993-5 (cytotoxicity), and ISO 10993-10 (sensitization/irritation). No clinical data provided.

Technological Characteristics

Wearable cap with 81 laser diodes; wavelength 650nm ±5nm; power 5mW ±10% per lamp. Class 3R laser product per IEC 60825-1. Patient-contacting materials compliant with ISO 10993-5 and ISO 10993-10. Powered device with built-in timing and IR-based proximity sensing for automatic shut-off.

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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January 30, 2018

Chongqing Peninsula Medical Technology Co., Ltd. % Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion No.121 Science Road, Guangzhou Science Park Guangzhou, 51006 China

Re: K171835

Trade/Device Name: Irradiation Aesthetic Device Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: October 29, 2017 Received: November 6, 2017

Dear Ms. Lee:

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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K171835

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.

# 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) K171835

Device Name Irradiation Aesthetic Device

### Indications for Use (Describe)

The Irradiation Aesthetic Device (Model: HairPro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa – 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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### 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.

#### Submitter Information 1.

Sponsor Name: Chongqing Peninsula Medical Technology Co., Ltd. Address: No.2-4, 2F Block I, Biological and Biochemical Park, 70-1&70-2# Ke Yuan 4th Road, Jiulongpo District, Chongqing, China Contact name: Zhang Sudi (RA) Tel: [phone] Fax: [phone] E-mail: [e-mail]

### Application Correspondent:

Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: [phone] Email: [e-mail]

#### Subject Device Information 2.

| Type of 510(k): | Traditional |
|----------------------|------------------------------|
| Trade Name: | Irradiation Aesthetic Device |
| Classification Name: | Infrared Lamp |
| Review Panel: | General & Plastic Surgery |
| Product Code: | OAP |
| Regulation Number: | 890.5500 |
| Regulation Class: | 2 |

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Sponsor: Chongqing Peninsula Medical Technology Co., Ltd Subject Device: Irradiation Aesthetic Device, Model: HairPro File No.: 510(k) submission report (V1.0), Chapter 23

#### Predicate Device Information 3.

Sponsor: Capillus LLC Classification Name: Infrared Lamp Trade Name: Capillus272, Capillus202, Capillus82 510(K) Number: K153618, K160285, K163170 Review Panel: General & Plastic Surgery Product Code: OAP Requlation Number: 890.5500 Regulation Class: 2

#### 4. Device Description

Irradiation Aesthetic Device (Model: HairPro) consists of laser diodes that are spread throughout the cap. The device 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. In the process of the cap working, the indicator blinks red based on the working frequency of the laser diodes. Built-in timing function, the cap can record the time per treatment, and the cap can stop working automatically after each 30 minutes treatment. When the built-in IR detected the cap is not worn on the head, the laser light output will be automatically suspended immediately and the cap will automatically shut down after 10 minutes.

#### 5. Intended Use

The Irradiation Aesthetic Device (Model: HairPro) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ila – V and for both. Fitzpatrick Classification of Skin Phototypes I to IV.

#### 6. Test Summary

Irradiation Aesthetic Device (Model: HairPro) has been evaluated the safety and performance by lab bench testing according to the following standards:

| Standards No. | Standard Title | Version | Date | Detail |
|---------------|----------------------------------------------------------------------------------------------|--------------|------------|---------------|
| IEC 60601-1 | Medical Electrical Equipment - Part 1: General Requirements for Safety | 2005+A1:2012 | 01/14/2014 | Attachment 10 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential | 2007 | 06/27/2016 | Attachment 10 |

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Chongqing Peninsula Medical Technology Co., Ltd Sponsor: Subject Device: Irradiation Aesthetic Device, Model: HairPro

| | performance - Collateral<br>standard: Electromagnetic<br>compatibility<br>Requirements and tests | | | |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------|------------------|
| IEC 60825-1 | Safety of laser products –<br>Part 1:<br>Equipment classification<br>and requirements | Second<br>edition:03/2007 | 03/2007 | Attachment<br>10 |
| IEC60601-1-11 | Medical Electrical<br>Equipment - Part 1-11:<br>General Requirements for<br>Basic Safety and Essential<br>Performance - Collateral<br>Standard: Requirements<br>for Medical Electrical<br>Equipment and Medical<br>Electrical Systems Used | 2010 | 03/1/2011 | Attachment<br>10 |
| ISO<br>10993-5<br>(Cytotoxicity) | Biological evaluation of<br>medical devices - Part 5:<br>Tests for In Vitro<br>cytotoxicity | 2009 | 05/05/2010 | Attachment<br>9 |
| ISO 10993-10<br>(Sensitization<br>and<br>Irritation) | Biological evaluation of<br>medical devices - Part 10:<br>Tests for irritation and skin<br>sensitization | 2010 | 03/16/2010 | Attachment<br>9 |

#### File No.: 510(k) submission report (V1.0), Chapter 23

#### Comparison to Predicate Device 7.

Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions 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 | Chongqing Peninsula<br>Medical Technology Co.,<br>Ltd. | Capillus LLC | | | -- |
| Trade Name | HairPro | Capillus82 | Capillus272 | Capillus202 | -- |
| Classification<br>Name | Infrared Lamp | Infrared Lamp | | | SE |
| 510(k) Number | K171835 | K163170 | K160285 | K153618 | -- |
| Product Code | OAP | OAP | | | SE |
| Intended Use /<br>Indications for<br>Use | The Irradiation Aesthetic<br>Device (Model: HairPro) is<br>indicated to promote hair<br>growth in females with<br>androgenetic alopecia whohave Ludwig-Savin<br>Classifications of I - II and<br>males with androgenetic | The<br>Capillus<br>laser<br>domes 82,<br>202, 272<br>Pro, 272<br>OfficePro,<br>302, 312, | The<br>Capillus272<br>Pro,<br>Capillus272<br>OfficePro,<br>Capillus82<br>and<br>Capillus202 | The<br>Capillus202<br>is indicated<br>to promote<br>hair growth<br>in females<br>with<br>Androgenet | SE |
| Elements of<br>Comparison | Subject Device | Predicate Device | | Verdict | |
| | alopecia who have<br>Norwood-Hamilton<br>Classifications of IIa - V and<br>for both, Fitzpatrick<br>Classification of Skin<br>Phototypes I to IV. | 352, are<br>intended to<br>treat<br>Androgeneti<br>c Alopecia<br>and<br>promote<br>hair growth<br>in males<br>who have<br>Norwood<br>Hamilton<br>Classificatio<br>ns of Ila to<br>V patterns<br>of hair loss<br>and to treat<br>Androgeneti<br>c Alopecia<br>and<br>promote<br>hair growth<br>in females<br>who have<br>Ludwig<br>(Savin)<br>Scale I-1 to<br>l-4, II-1, II-<br>2, or frontal;<br>both with<br>Fitzpatrick<br>Skin Types<br>l to IV. | are<br>intended to<br>treat the<br>promote<br>hair growth<br>in females<br>with<br>Androgenet<br>ic Alopecia<br>who have<br>Ludwig<br>(Savin)<br>Scale I-II,<br>and in<br>males with<br>androgenic<br>alopecia<br>who have<br>Norwood<br>Hamilton<br>Classificatio<br>ns lia-V;<br>and both<br>genders<br>having<br>Fitzpatrick<br>Classificatio<br>ns of Skin<br>Prototypes I<br>to IV.ic Alopecia<br>who have<br>Ludwig-<br>Savin<br>Classificatio<br>ns of I-II,<br>and with<br>Fitzpatrick<br>Skin Types<br>l to IV. | | |
| Waveform | Visible red laser | Visible red laser | | SE | |
| Wavelength | 650nm±5nm | 650nm | | SE | |
| Amounts of Laser<br>Lamp | 81 | Capillus272 Pro: 272<br>Capillus202: 202<br>Capillus82: 82 | | SE<br>Note 1 | |
| Energy of per<br>Laser Lamp | 5mW ±10% | <5mW | | SE<br>Note 1 | |
| Classification<br>according to<br>IEC60825-1 | Class 3R | Class 3R | | SE | |
| Treatment Time | Each Treatment: 30 min<br>Total Treatment: 3 times per | Each Treatment: 30 min<br>Total Treatment: every other day, for 17 | | SE<br>Note 1 | |

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Sponsor: Subject Device:

Chongqing Peninsula Medical Technology Co., Ltd Irradiation Aesthetic Device, Model: HairPro File No.: 510(k) submission report (V1.0), Chapter 23

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Sponsor: Chongqing Peninsula Medical Technology Co., Ltd Subject Device: Irradiation Aesthetic Device, Model: HairPro File No.: 510(k) submission report (V1.0), Chapter 23

| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
|--------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------|
| week | | weeks. | |
| Treatment Area | 202.3 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 (power<br>per area) | 2.2022 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 | 3.9639 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 | 199mm*179mm*88mm (L x<br>W x H) | -- | SE<br>Note 2 |
| Life Expectancy | 5 years | -- | SE |
| Weight | 1000g | -- | SE |
| Environment for<br>Operation | Temperature: 5°C~30°C<br>Humidity: ≤ 80%<br>Atmosphere range: 700hPa-<br>1060hPa | -- | SE<br>Note 2 |
| Environment for<br>Storage | Temperature: 0°C~50°C<br>Humidity: ≤ 85%<br>Atmosphere range: 50kPa-<br>110kPa | -- | SE<br>Note 2 |
| Safety Feature | Complied with IEC 60601-1<br>and IEC 60601-1-2 | Complied with IEC 60601-1 and IEC<br>60601-1-2 | SE |
| Biocompatibility<br>Feature | All patient contacting<br>materials are complied with<br>ISO 10993-5, ISO 10993-10 | All patient contacting materials are<br>complied with ISO 10993-5, ISO 10993-<br>10 | SE |

### Comparison in Detail(s):

### Note 1:

Although "Amounts of Laser Lamp", "Treatment Area", "Irradiance (power per area)" and "Fluence" of the subject device are different from the predicate devices, however, 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.

### Note 2:

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Sponsor: Chongqing Peninsula Medical Technology Co., Ltd Subject Device: Irradiation Aesthetic Device, Model: HairPro File No.: 510(k) submission report (V1.0), Chapter 23

"Dimension", "Weight", "Environment for Operation" and "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 Irradiation Aesthetic Device (Model: HairPro) has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.

## 9. Summary Prepared Date 26 January 2018