Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on laser technology, timing functions, and safety features based on IR detection. There is no mention of AI, ML, or any data processing that would suggest such capabilities.

Therapeutic

Yes.
The device is intended to promote hair growth in individuals with androgenetic alopecia, which addresses a medical condition, classifying it as therapeutic.

Diagnostic

No

The provided text only describes the device's function in promoting hair growth and its safety/performance testing, not any diagnostic capabilities. Its intended use is therapeutic, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly states it "consists of laser diodes that are spread throughout the cap" and describes hardware components like indicator lights and IR sensors, indicating it is a physical device with embedded software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The Irradiation Aesthetic Device (Model: HairPro) is a device that uses laser light applied externally to the scalp to promote hair growth. It does not analyze any biological samples.
Intended Use: The intended use is to treat androgenetic alopecia by promoting hair growth, which is a therapeutic or aesthetic application, not a diagnostic one.
Device Description: The description focuses on the physical components and how the laser light is delivered to the scalp. There is no mention of sample collection, analysis, or diagnostic results.

Therefore, the HairPro device falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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

Product codes

OAP

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

head (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

Irradiation Aesthetic Device (Model: HairPro) has been evaluated the safety and performance by lab bench testing according to the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC60601-1-11, ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization and Irritation).

Key Metrics

Not Found

Predicate Device(s)

K163170, K160285, K153618

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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);

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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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3

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: +86-150 1257 8550 Fax: 023-6861 1963 E-mail: zsd@peninsulalaser.com

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: +86-20-61099984 Email: regulatory@glomed-info.com

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

4

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

5

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

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

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