Diode Laser Cap

• K Number: K173678
• Device Name: Diode Laser Cap
• Manufacturer: Cosmo Far East Technology Limited
• Date Cleared: 2018-02-28 ( 90 days)
• Product Code: OAP
• Regulation Number: 890.5500

Intended Use

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.

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 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).

Predicate Devices

K162071, K163170

Reference Devices

None

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on low-level laser therapy and electrical/EMC safety, with no mention of AI or ML technologies.

Therapeutic

Yes
The device is indicated to "promote hair growth" for a medical condition (androgenic alopecia), which describes a therapeutic effect.

Diagnostic

No.
The device description and intended use clearly state that the Diode Laser Cap is designed to promote hair growth through low-level laser therapy (LLLT), which is a treatment and not a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "dome-shaped low level laser therapy (LLLT) device" with an "outer plastic cover and a protective inner (containing the electronics and laser array)" and is "powered by an included battery pack." This indicates it is a physical hardware device, not software only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• Device Function: The Diode Laser Cap is a therapeutic device that applies light energy directly to the scalp to stimulate hair growth. It does not analyze any biological samples.
• Intended Use: The intended use is to promote hair growth, not to diagnose or monitor a condition based on in vitro analysis.
• Device Description: The description clearly outlines a device that emits light and is applied externally. There is no mention of collecting or analyzing biological specimens.

Therefore, based on the provided information, the Diode Laser Cap falls under the category of a therapeutic device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

OAP

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 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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

scalp

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K162071, K163170

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

None

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
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.(b)
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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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
use/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 to IV.	The illumiflow 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 to IV	The Capillus laser
domes 82, 202, 272
Pro, 272 OfficePro,
302, 312, and 352, are
intended to treat
Androgenetic
Alopecia and promote
hair growth in males
who have Norwood
Hamilton
Classifications of IIa
to V patterns of hair
loss and to treat
Androgenetic
Alopecia and promote
hair growth in females
Comparison
Elements	Subject Device	Predicate Device 1	Predicate Device 2
			who have Ludwig
(Savin) Scale I-1 to I-
4, II-1, II-2, or frontal;
both with Fitzpatrick
Skin Types I to IV.
Location for use	OTC application	OTC application	OTC application
Type of Light	Visible red light-
emitting diodes	Visible red light-
emitting diodes	Visible red light-
emitting diodes
Wavelength	650nm	650nm	650nm
Amount of laser
diodes	COSMO-010: 272
COSMO-020: 148
COSMO-030: 272	272	Capillus 82: 82
Capillus 202: 202
Capilus 272 Pro: 272
Energy of per laser
diode	5mW	5mW	5mW
Classification
according
to
IEC60825-1	Class 3R	Class 3R	Class 3R
Treatment time	Each treatment: 30min
16 weeks, every other
day (indefinite)	Each treatment: 30min
16 weeks, every other
day (indefinite)	Each treatment: 30min
17 weeks, every other
day (indefinite)
Applicable people	Norwood-Hamilton
IIa~V (males)	Norwood-Hamilton
IIa~V (males)	Norwood-Hamilton
IIa~V (males)
	Ludwig-Savin I~II
(females)	Ludwig-Savin I~II
(females)	Ludwig-Savin I~II or
frontal (females)
Applicable skin	Fitzpatrick Skin
Phototypes I-IV	Fitzpatrick Skin
Phototypes I-IV	Fitzpatrick Skin
Phototypes I-IV
Helmet/Cap design	Yes	Yes	Yes
Dimension	(LWH)
COSMO-010:
23189cm
COSMO-020:
22189cm
COSMO-030:	Perimeter: 61cm
Diameter: 19cm	Unknown
Comparison
Elements	Subject Device	Predicate Device 1	Predicate Device 2
	22189cm
Weight	COSMO-010: 0.22kg
COSMO-020: 0.26kg
COSMO-030: 0.26kg	0.22kg	Unknown
Environment
for
operation	Temperature: 10 °C
30°C (50°F86°F)
Humidity: 20%~80%	Temperature: -10 °C
60°C (14°F140°F)
Humidity: 20%~80%	Temperature: 5 °C
40°C (41°F104°F)
Humidity: 30%~80%
Environment
for
storage	Temperature: -10 °C
60°C (14°F140°F)
Humidity: 20%~80%	Temperature: -10 °C
60°C (14°F140°F)
Humidity: 20%~80%	Unknown
Safety feature	Complied with
IEC60601-1,
IEC60601-1-11,
IEC60601-1-2 and
IEC60825-1
Complied with
IEC62133 (Battery
pack)
Complied with
IEC60950 (Adapter)	Complied with
IEC60601-1,
IEC60601-1-2 and
IEC60825-1
Complied with
IEC62133 (Battery)
Complied with
IEC60950 (Charger)	Complied with
IEC60825-1
Complied with
IEC60950 (Charger)
Biocompatibility
feature	All body-contacting
materials are complied
with ISO10993-5 and
ISO 10993-10.	All body-contacting
materials are complied
with ISO10993-5 and
ISO 10993-10.	All body-contacting
materials are complied
with ISO10993-5 and
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

7

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.