(213 days)
Not Found
No
The device description focuses on laser technology, timing functions, and safety features based on IR detection. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated to "promote hair growth" for a medical condition (androgenetic alopecia), which is a therapeutic purpose.
No
The device is indicated to promote hair growth and is described as an "Irradiation Cosmetic Device" that uses laser diodes for treatment, not for diagnosis.
No
The device description explicitly states it "consists of laser diodes that are spread throughout the cap" and mentions "Built-in timing function" and "built-in IR detected the cap is not worn on the head," indicating the presence of hardware components beyond just software.
Based on the provided information, 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 Irradiation Cosmetic Device (Model: HairPro Plus) is a device that applies laser light 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, which is a therapeutic or cosmetic application, not a diagnostic one.
- Device Description: The description focuses on the physical components and operation of the laser cap, not on any analytical or testing capabilities.
Therefore, this device falls under the category of a therapeutic or cosmetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Irradiation Cosmetic Device (Model: HairPro Plus) 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 Cosmetic Device (Model: HairPro Plus) 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 (hair)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
Irradiation Cosmetic Device (Model: HairPro Plus) has been evaluated the safety and performance by lab bench testing according to the following standards:
IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety (2005+A1:2012, 07/09/2014)
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 (2014, 09/17/2018)
IEC 60825-1 Safety of laser products - Part 1: Equipment classification and requirements (Second edition:03/2007, 07/09/2014)
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 (2015-1, 06/27/2016)
ISO 10993-5 (Cytotoxicity) Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity (2009/(R)2014, 12/23/2016)
ISO 10993-10 (Sensitization and Irritation) Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (2010/(R)2014, 07/26/2016)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows 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 is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".
Chongqing Peninsula Medical Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, 51006 China
Re: K192552
Trade/Device Name: Irradiation Cosmetic Device Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: February 28, 2020 Received: March 11, 2020
Dear Cassie 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. 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 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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin Kejing Chen 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
2
Indications for Use
510(k) Number (if known) K192552
Device Name Irradiation Cosmetic Device
Indications for Use (Describe)
The Irradiation Cosmetic Device (Model: HairPro Plus) 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 requirement of 21 CFR 807.92.
1. Submitter Information
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: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
Subject Device Information 2.
| Type of 510(k): | Traditional |
|---|---|
| Trade Name: | Irradiation Cosmetic Device |
| Model Name: | HairPro Plus |
| Classification Name: | Infrared Lamp |
| Review Panel: | General & Plastic Surgery |
| Product Code: | OAP |
| Regulation Number: | 890.5500 |
| Regulation Class: | 2 |
Predicate Device (1) Information 3.
Sponsor: Chongqing Peninsula Medical Technology Co., Ltd.
Classification Name: Infrared Lamp
4
Sponsor: Chongqing Peninsula Medical Technology Co., Ltd Subject Device: Irradiation Cosmetic Device, Model: HairPro Plus File No.: 510(k) summary (V1.0)
Trade Name: Irradiation Aesthetic Device Model name: HairPro 510(K) Number: K171835 Review Panel: General & Plastic Surgery Product Code: OAP Requlation Number: 890.5500 Requlation Class: 2
Predicate Device (2) Information:
Sponsor: Capillus LLC Classification Name: Infrared Lamp Trade Name: Capillus272 510(K) Number: K153618 Review Panel: General & Plastic Surgery Product Code: OAP Requlation Number: 890.5500 Requlation Class: 2
4. Device Description
Irradiation Cosmetic Device (Model: HairPro Plus) 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 Cosmetic Device (Model: HairPro Plus) is indicated to promote hair growth in females with androqenetic 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
5
| Sponsor: | Chongqing Peninsula Medical Technology Co., Ltd |
|---|---|
| Subject Device: | Irradiation Cosmetic Device, Model: HairPro Plus |
| File No.: | 510(k) summary (V1.0) |
Irradiation Cosmetic Device (Model: HairPro Plus) 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: General Requirements | |||
| for Safety | 2005+A1:2012 | 07/09/2014 | |
| 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 | 2014 | 09/17/2018 | |
| IEC 60825-1 | Safety of laser products - Part | ||
| 1: | |||
| Equipment classification and | |||
| requirements | Second | ||
| edition:03/2007 | 07/09/2014 | ||
| 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 | 2015-1 | 06/27/2016 | |
| ISO 10993-5 (Cytotoxicity) | Biological evaluation of | ||
| medical devices - Part 5: Tests | |||
| for In Vitro cytotoxicity | 2009/(R)2014 | 12/23/2016 | |
| ISO 10993-10 | |||
| (Sensitization and | |||
| Irritation) | Biological evaluation of | ||
| medical devices - Part 10: | |||
| Tests for irritation and skin | |||
| sensitization | 2010/(R)2014 | 07/26/2016 |
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 1 | Predicate Device 2 | Verdict |
|---|---|---|---|---|
| Company | Chongqing Peninsula Medical Technology Co., Ltd. | Chongqing Peninsula Medical Technology Co., Ltd. | Capillus LLC | SE |
| Trade Name | Irradiation Cosmetic Device | |||
| (model:HairPro Plus) | Irradiation Aesthetic Device | |||
| HairPro | Capillus272 Pro, | |||
| Capillus272 OfficePro, | ||||
| Capillus82, | ||||
| Capillus202 | SE | |||
| Elements | ||||
| of | ||||
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
| Classification | ||||
| Name | Infrared Lamp | Infrared Lamp | Infrared Lamp | SE |
| 510(k) Number | Applying | K171835 | K160285 | -- |
| Product Code | OAP | OAP | OAP | SE |
| Intended Use / | ||||
| Indications for | ||||
| Use | The Irradiation | |||
| Cosmetic Device | ||||
| (Model: HairPro Plus) | ||||
| 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. | The Irradiation | |||
| Cosmetic 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. | The Capillus272 | |||
| Pro, Capillus272 | ||||
| OfficePro. | ||||
| Capillus82, and | ||||
| Capillus202 are | ||||
| intended for the | ||||
| promotion of hair | ||||
| growth in females | ||||
| with androgenic | ||||
| alopecia who have | ||||
| Ludwig-Savin | ||||
| Classifications I- II, | ||||
| and in males with | ||||
| androgenic alopecia | ||||
| who have Norwood | ||||
| Hamilton | ||||
| Classifications Ila- | ||||
| V ; and both | ||||
| genders having | ||||
| Fitzpatrick | ||||
| Classification of | ||||
| Skin Phototypes I to | ||||
| IV. | SE | |||
| Waveform | Visible red laser | Visible red laser | Visible red laser | SE |
| Wavelength | 650nm±5nm | 650nm±5nm | 650 | SE |
| Amounts of Laser | ||||
| Lamp | 272 | 81 | Capillus272 Pro: | |
| 272 | ||||
| Capillus202: 202 | ||||
| Capillus82: 82 | SE | |||
| Energy of per | ||||
| Laser Lamp | 5mW ±10% | 5mW ±10% |