(213 days)
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
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.
The provided FDA 510(k) summary for the "Irradiation Cosmetic Device (Model: HairPro Plus)" describes a device clearance based on substantial equivalence to predicate devices, rather than a study demonstrating clinical performance against established acceptance criteria for a new clinical claim.
Therefore, the information requested regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies supporting novel clinical claims for AI/ML-driven devices, is largely not applicable to this submission. This device is cleared based on demonstrating that it is as safe and effective as existing legally marketed predicate devices, primarily through engineering and biocompatibility testing.
Here's an breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The submission does not present a table of specific clinical acceptance criteria with corresponding performance metrics for hair growth promotion. Instead, the "acceptance criteria" are implied by compliance with various safety and performance standards for medical electrical equipment and biocompatibility, as well as demonstrating substantial equivalence to predicate devices in their design, intended use, and specifications.
The table in the document (pages 5-6) is a comparison table to predicate devices, not a performance table against clinical acceptance criteria for the subject device itself. It indicates that the subject device's specifications (e.g., wavelength, energy, treatment time, irradiance, fluence) are comparable to those of the predicate devices. The "Verdict" column indicates "SE" (Substantial Equivalence) rather than a specific performance measure.
| Elements of Comparison | Subject Device (Irradiation Cosmetic Device, Model: HairPro Plus) Performance/Specification | Predicate Device 1 (HairPro) Performance/Specification | Predicate Device 2 (Capillus272 Pro, etc.) Performance/Specification | Acceptance Criteria (Implied by Substantial Equivalence and Standards) |
|---|---|---|---|---|
| Intended Use / Indications for Use | Promote hair growth in females (Ludwig-Savin Class I-II) and males (Norwood-Hamilton Class IIa-V) with androgenetic alopecia, Fitzpatrick Skin Phototypes I-IV. | Same | Same | Substantially equivalent to predicate devices. |
| Wavelength | 650nm ±5nm | 650nm ±5nm | 650nm | Within range of predicate devices. |
| Energy per Laser Lamp | 5mW ±10% | 5mW ±10% | <5mW | Within range of predicate devices. |
| Number of Laser Lamps | 272 | 81 | Capillus272 Pro: 272, Capillus202: 202, Capillus82: 82 | Within range of predicate devices. |
| Treatment Time | Each Treatment: 30 min, Total Treatment: 3 times per week | Each Treatment: 30 min, Total Treatment: 3 times per week | Each Treatment: 30 min, Total Treatment: every other day, for 17 weeks. | Comparable to predicate devices. |
| Irradiance | 2.7454 mW/cm² (Mathematically Max. derived) | 2.2022 mW/cm² (Mathematically Max. derived) | Capillus272: 2.7454 mW/cm²; Capillus202: 2.2469 mW/cm²; Capillus82: 2.1088 mW/cm² (Mathematically Max. derived) | Comparable to predicate devices. |
| Fluence | 4.9417 J/cm² (Mathematically Max. derived) | 3.9639 J/cm² (Mathematically Max. derived) | Capillus272: 4.9417 J/cm²; Capillus202: 4.044 J/cm²; Capillus82: 3.7920 J/cm² (Mathematically Max. derived) | Comparable to predicate devices. |
| Safety Feature | Complied with IEC 60601-1 and IEC 60601-1-2 | Complied with IEC 60601-1 and IEC 60601-1-2 | Complied with IEC 60601-1 and IEC 60601-1-2 | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC60601-1-11. |
| Biocompatibility Feature | All patient contacting materials complied with ISO 10993-5, ISO 10993-10 | All patient contacting materials complied with ISO 10993-5, ISO 10993-10 | All patient contacting materials complied with ISO 10993-5, ISO 10993-10 | Compliance with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Irritation). |
2. Sample size used for the test set and the data provenance
No clinical test set of patients or medical images is described for this submission. The tests performed are laboratory bench tests and comparisons to predicate device specifications. Therefore, information about sample size and data provenance for a test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring expert ground truth establishment was conducted for this 510(k) submission.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication was conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The submission relies on substantial equivalence to predicate devices, supported by engineering and biocompatibility testing, not human-in-the-loop performance studies comparing AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Based on the provided document, the "Irradiation Cosmetic Device" is a hardware device (laser cap) for promoting hair growth. It does not appear to be an AI/ML algorithm or software device that would have "standalone performance" in the typical sense of AI/ML. The performance demonstrated is related to its physical specifications, safety, and biocompatibility, as compared to predicate devices.
7. The type of ground truth used
For the safety and performance evaluations, the "ground truth" is implied by compliance with international standards (IEC, ISO) for electrical safety, electromagnetic compatibility, laser safety, and biocompatibility. For the substantial equivalence claim, the "ground truth" is the established safety and effectiveness profile of the predicate devices. There is no mention of a ground truth established from expert consensus, pathology, or outcomes data related to hair growth efficacy for the subject device within this 510(k) summary. Efficacy for hair growth is assumed due to the substantial equivalence to predicate devices that have prior clearance for this indication.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device that requires a training set.
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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
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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
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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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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
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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
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| 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 Requirementsfor Safety | 2005+A1:2012 | 07/09/2014 |
| IEC 60601-1-2 | Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility - Requirementsand tests | 2014 | 09/17/2018 |
| IEC 60825-1 | Safety of laser products - Part1:Equipment classification andrequirements | Secondedition:03/2007 | 07/09/2014 |
| IEC60601-1-11 | Medical Electrical Equipment -Part 1-11: GeneralRequirements for Basic Safetyand Essential Performance -Collateral Standard:Requirements for MedicalElectrical Equipment andMedical Electrical SystemsUsed | 2015-1 | 06/27/2016 |
| ISO 10993-5 (Cytotoxicity) | Biological evaluation ofmedical devices - Part 5: Testsfor In Vitro cytotoxicity | 2009/(R)2014 | 12/23/2016 |
| ISO 10993-10(Sensitization andIrritation) | Biological evaluation ofmedical devices - Part 10:Tests for irritation and skinsensitization | 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 DeviceHairPro | Capillus272 Pro,Capillus272 OfficePro,Capillus82,Capillus202 | SE |
| ElementsofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
| ClassificationName | Infrared Lamp | Infrared Lamp | Infrared Lamp | SE |
| 510(k) Number | Applying | K171835 | K160285 | -- |
| Product Code | OAP | OAP | OAP | SE |
| Intended Use /Indications forUse | The IrradiationCosmetic Device(Model: HairPro Plus)is indicated to promotehair growth in femaleswith androgeneticalopecia who haveLudwig-SavinClassifications of I - IIand males withandrogenetic alopeciawho have Norwood-HamiltonClassifications of Ila -V and for both,FitzpatrickClassification of SkinPhototypes I to IV. | The IrradiationCosmetic Device(Model: HairPro) isindicated to promotehair growth in femaleswith androgeneticalopecia who haveLudwig-SavinClassifications of I - IIand males withandrogenetic alopeciawho have Norwood-HamiltonClassifications of Ila -V and for both,FitzpatrickClassification of SkinPhototypes I to IV. | The Capillus272Pro, Capillus272OfficePro.Capillus82, andCapillus202 areintended for thepromotion of hairgrowth in femaleswith androgenicalopecia who haveLudwig-SavinClassifications I- II,and in males withandrogenic alopeciawho have NorwoodHamiltonClassifications Ila-V ; and bothgenders havingFitzpatrickClassification ofSkin Phototypes I toIV. | SE |
| Waveform | Visible red laser | Visible red laser | Visible red laser | SE |
| Wavelength | 650nm±5nm | 650nm±5nm | 650 | SE |
| Amounts of LaserLamp | 272 | 81 | Capillus272 Pro:272Capillus202: 202Capillus82: 82 | SE |
| Energy of perLaser Lamp | 5mW ±10% | 5mW ±10% | <5mW | SE |
| Classificationaccording toIEC60825-1 | Class 3R | Class 3R | Class 3R | SE |
| Treatment Time | Each Treatment: 30minTotal Treatment: 3times per week | Each Treatment: 30minTotal Treatment: 3times per week | Each Treatment: 30minTotal Treatment:every other day, for17 weeks. | SE |
| Treatment Area | 495.37 cm²Mathematically Max.derived | 202.3 cm²Mathematically Max.derived | Capillus272: 495.37cm2Capillus202: 449.51cm2Capillus82: 194.42cm2 | SE |
| ElementsofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
| MathematicallyMax. derived | ||||
| Irradiance (powerper area) | 2.7454 mW/cm²Mathematically Max.derived | 2.2022 mW/cm²Mathematically Max.derived | Capillus272: 2.7454mW/cm²Capillus202: 2.2469mW/cm²Capillus82: 2.1088mW/cm²MathematicallyMax. derived | SE |
| Fluence | 4.9417 J/cm²Mathematically Max.derived | 3.9639 J/cm²Mathematically Max.derived | Capillus272: 4.9417J/cm²Capillus202: 4.044J/cm²Capillus82: 3.7920J/cm²MathematicallyMax. derived | SE |
| Dimension | 199mm179mm88mm (L x W x H) | 199mm179mm88mm (L x W x H) | -- | SE |
| Life Expectancy | 5 years | 5 years | -- | SE |
| Weight | 1100g | 1000g | -- | SE |
| Environment forOperation | Temperature:5°C~30°CHumidity: ≤ 80%Atmosphere range:700hPa-1060hPa | Temperature:5°C~30°CHumidity: ≤ 80%Atmosphere range:700hPa-1060hPa | -- | SE |
| Environment forStorage | Temperature:0°C~50°CHumidity: ≤ 85%Atmosphere range:50kPa-110k | Temperature:0°C~50°CHumidity: ≤ 85%Atmosphere range:50kPa-110k | -- | SE |
| Safety Feature | Complied with IEC60601-1 and IEC60601-1-2 | Complied with IEC60601-1 and IEC60601-1-2 | Complied with IEC60601-1 and IEC60601-1-2 | SE |
| BiocompatibilityFeature | All patient contactingmaterials are compliedwith ISO 10993-5, ISO10993-10 | All patient contactingmaterials are compliedwith ISO 10993-5, ISO10993-10 | All patientcontacting materialsare complied withISO 10993-5, ISO10993-10 | SE |
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Chongqing Peninsula Medical Technology Co., Ltd Sponsor: Subject Device: Irradiation Cosmetic Device, Model: HairPro Plus File No.: 510(k) summary (V1.0)
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Sponsor: Chongqing Peninsula Medical Technology Co., Ltd Subject Device: Irradiation Cosmetic Device, Model: HairPro Plus File No.: 510(k) summary (V1.0)
Final Conclusion
The subject device Irradiation Cosmetic Device (Model: HairPro Plus) 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.
8. Summary Prepared Date 11 April 2020
§ 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.