Diode Laser Cap

K173678 · Cosmo Far East Technology Limited · OAP · Feb 28, 2018 · Physical Medicine

Device Facts

• Record ID: K173678
• Device Name: Diode Laser Cap
• Applicant: Cosmo Far East Technology Limited
• Product Code: OAP · Physical Medicine
• Decision Date: Feb 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Diode Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.

Device Story

Diode Laser Cap is a dome-shaped low-level laser therapy (LLLT) device for home use. It utilizes 148 or 272 visible red light-emitting diodes (650nm, 5mW each) to expose the scalp to photobiostimulation. The device consists of an outer plastic cover, an inner protective layer containing the laser array and electronics, and an external battery pack. Patients operate the device independently for 30-minute sessions, every other day, for 16 weeks. The device is intended to promote hair growth in patients with androgenic alopecia. It does not involve complex software or automated analysis; it functions as a light-delivery system.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety (IEC 60601-1, IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), and laser safety (IEC 60825-1).

Technological Characteristics

Dome-shaped LLLT device; 148 or 272 red LEDs (650nm, 5mW each); Class 3R laser (IEC 60825-1); battery-powered; plastic housing; biocompatible materials (ISO 10993-5/10); home-use environment; no software-based algorithm.

Indications for Use

Indicated for males with androgenic alopecia (Norwood-Hamilton IIa-V) or females with androgenic alopecia (Ludwig-Savin I-II) with 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

• illumiflow Laser Cap (K162071)
• Capillus laser domes (K163170)

Submission Summary (Full Text)

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February 28, 2018

Cosmo Far East Technology Limited % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road Shenzhen, 518000 Cn

Re: K173678

Trade/Device Name: Diode Laser Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: November 21, 2017 Received: November 30, 2017

Dear Rain Yip:

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

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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); 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)

K173678

Device Name

Diode Laser Cap /(Model: COSMO-030, COSMO-020, COSMO-010)

Indications for Use (Describe)

Diode Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes 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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# 510(k) Summary

### "510(k) Summary" as required by 21 CFR Part 807.92.

#### Date: 2017.11.21

#### I. Submitter

Cosmo Far East Technology Limited Room 1504, Building 1, XingJiJia Yuan, Bao'an Avenue, Songgang, Bao'an District, Shenzhen, Guangdong, China

Tel.: [phone] Tax: [phone]

Bob An (General Manager) Tel: [phone] Email: [e-mail]

#### II. Device

Type of 510(k): Traditional Common Name: Lamp, non-heating, for promotion of hair growth Trade Name: Diode Laser Cap Classification Name: Infrared lamp per 21 CFR 890.5500 Review Panel: General & Plastic Surgery Regulatory Class: II Product Code: OAP Regulation Number: 21 CFR 890.5500

#### III. Predicate Device

- 1) Predicate device

| Applicant | Predicate Device | 510(k) Number | Approval Date |
|---------------|----------------------|---------------|---------------|
| EGlobal, LLC | illumiflow Laser Cap | K162071 | Feb.24. 2017 |
| Capillus, LLC | Capillus laser domes | K163170 | Jan.31, 2017 |

2) Reference device: None

#### IV. Device Description

The COSMO-030 and COSMO-010 Diode Laser Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272visible red light-emitting diodes at 650nm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner (containing the electronics

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and laser array) and is powered by an included battery pack. The COSMO-020 Diode Laser Cap is exactly the same as the COSMO-030 with the exception of the number of diodes which is respective of model (148 diodes in COSMO-020).

# V. Indications for Use

Diode Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.

# VI. Comparison of Technological Characteristics With the Predicate Device

The Diode Laser Cap is substantially equivalent to the predicated device based on intended use, design, specifications and performance.

The Diode Laser Cap raises no safety or efficacy concerns when compared to the predicate devices.

Information for predicate device was obtained from publicly available sources, including the 510(k) Summary and device instruction manual. A technical comparison to the predicate is provided below:

| Comparison<br>Elements | Subject Device | Predicate Device 1 | Predicate Device 2 |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | Pending | K162071 | K161370 |
| Trade name | Diode Laser Cap | illumiflow Laser Cap | Capillus laser domes |
| Classification name | Infrared Lamp | Infrared Lamp | Infrared Lamp |
| Product code | OAP | OAP | OAP |
| Intended<br>use/Indications<br>for<br>Use | Diode Laser Cap is<br>indicated to promote<br>hair growth in males<br>with androgenic<br>alopecia who have<br>Norwood-Hamilton<br>classifications of<br>IIa~V or females with<br>androgenic alopecia<br>who have Ludwig-<br>Savin Classifications<br>of I~II and both with<br>Fitzpatrick Skin<br>Phototypes I to IV. | The illumiflow Laser<br>Cap is indicated to<br>promote hair growth<br>in males with<br>androgenic alopecia<br>who have Norwood-<br>Hamilton<br>classifications of<br>IIa~V or females with<br>androgenic alopecia<br>who have Ludwig-<br>Savin Classifications<br>of I~II and both with<br>Fitzpatrick Skin<br>Phototypes I to IV | The Capillus laser<br>domes 82, 202, 272<br>Pro, 272 OfficePro,<br>302, 312, and 352, are<br>intended to treat<br>Androgenetic<br>Alopecia and promote<br>hair growth in males<br>who have Norwood<br>Hamilton<br>Classifications of IIa<br>to V patterns of hair<br>loss and to treat<br>Androgenetic<br>Alopecia and promote<br>hair growth in females |
| Comparison<br>Elements | Subject Device | Predicate Device 1 | Predicate Device 2 |
| | | | who have Ludwig<br>(Savin) Scale I-1 to I-<br>4, II-1, II-2, or frontal;<br>both with Fitzpatrick<br>Skin Types I to IV. |
| Location for use | OTC application | OTC application | OTC application |
| Type of Light | Visible red light-<br>emitting diodes | Visible red light-<br>emitting diodes | Visible red light-<br>emitting diodes |
| Wavelength | 650nm | 650nm | 650nm |
| Amount of laser<br>diodes | COSMO-010: 272<br>COSMO-020: 148<br>COSMO-030: 272 | 272 | Capillus 82: 82<br>Capillus 202: 202<br>Capilus 272 Pro: 272 |
| Energy of per laser<br>diode | 5mW | 5mW | 5mW |
| Classification<br>according<br>to<br>IEC60825-1 | Class 3R | Class 3R | Class 3R |
| Treatment time | Each treatment: 30min<br>16 weeks, every other<br>day (indefinite) | Each treatment: 30min<br>16 weeks, every other<br>day (indefinite) | Each treatment: 30min<br>17 weeks, every other<br>day (indefinite) |
| Applicable people | Norwood-Hamilton<br>IIa~V (males) | Norwood-Hamilton<br>IIa~V (males) | Norwood-Hamilton<br>IIa~V (males) |
| | Ludwig-Savin I~II<br>(females) | Ludwig-Savin I~II<br>(females) | Ludwig-Savin I~II or<br>frontal (females) |
| Applicable skin | Fitzpatrick Skin<br>Phototypes I-IV | Fitzpatrick Skin<br>Phototypes I-IV | Fitzpatrick Skin<br>Phototypes I-IV |
| Helmet/Cap design | Yes | Yes | Yes |
| Dimension | (L*W*H)<br>COSMO-010:<br>23*18*9cm<br>COSMO-020:<br>22*18*9cm<br>COSMO-030: | Perimeter: 61cm<br>Diameter: 19cm | Unknown |
| Comparison<br>Elements | Subject Device | Predicate Device 1 | Predicate Device 2 |
| | 22*18*9cm | | |
| Weight | COSMO-010: 0.22kg<br>COSMO-020: 0.26kg<br>COSMO-030: 0.26kg | 0.22kg | Unknown |
| Environment<br>for<br>operation | Temperature: 10 °C<br>~30°C (50°F~86°F)<br>Humidity: 20%~80% | Temperature: -10 °C<br>~60°C (14°F~140°F)<br>Humidity: 20%~80% | Temperature: 5 °C<br>~40°C (41°F~104°F)<br>Humidity: 30%~80% |
| Environment<br>for<br>storage | Temperature: -10 °C<br>~60°C (14°F~140°F)<br>Humidity: 20%~80% | Temperature: -10 °C<br>~60°C (14°F~140°F)<br>Humidity: 20%~80% | Unknown |
| Safety feature | Complied with<br>IEC60601-1,<br>IEC60601-1-11,<br>IEC60601-1-2 and<br>IEC60825-1<br>Complied with<br>IEC62133 (Battery<br>pack)<br>Complied with<br>IEC60950 (Adapter) | Complied with<br>IEC60601-1,<br>IEC60601-1-2 and<br>IEC60825-1<br>Complied with<br>IEC62133 (Battery)<br>Complied with<br>IEC60950 (Charger) | Complied with<br>IEC60825-1<br>Complied with<br>IEC60950 (Charger) |
| Biocompatibility<br>feature | All body-contacting<br>materials are complied<br>with ISO10993-5 and<br>ISO 10993-10. | All body-contacting<br>materials are complied<br>with ISO10993-5 and<br>ISO 10993-10. | All body-contacting<br>materials are complied<br>with ISO10993-5 and<br>ISO 10993-10. |

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## VII.Performance Data

The following performance data were provided in support of the substantial equivalence determination.

# 1) Biocompatibility Testing

The biocompatibility evaluation for the body-contacting components of the Diode Laser Cap was conducted in accordance with the "Use of International Standard ISO 10993-1, "Biological

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Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:

- > ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
- > ISO 10993-10:2010. Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization

## 2) Electrical and EMC Safety

Electrical safety and EMC safety testing was performed to, and passed, the following standards:

- > IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- > IEC 60601-1-11 Medical electrical equipment -Part 1-11: General requirements for basic safety and essential performance -Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- > IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility -Requirements and tests

In addition, testing to IEC 60825-1 certifies the laser system to classification 3R, which is the same as the predicate devices. And the charger conforms to IEC 60950 and the battery to IEC 62133.

### Summary

Based on the above performance as documented in this application, Diode Laser Cap was found to have a safety and effectiveness profile that is similar to the predicate device.

#### VIII. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the Diode Laser Cap is to be concluded substantial equivalent to its predicate devices.