(86 days)
LLLT Laser Hair Growth 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.
LLLT Laser Hair Growth 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 visible red light-emitting diodes at 650mm and 5mW each. LLLT Laser Hair Growth Cap includes three models, Hair Care 210, Hair Care 135 and Hair Care 210 (210 diodes) is the typical model, Hair Care 135 (135 diodes) and Hair Care 88 (88 diodes) are exactly the same as the Hair Care 210 regarding structure design, intended use, performance and operation, with the difference being the diode amount. Each model has three colors, which are white, hidden color and pool blue.
This document is a 510(k) Pre-Market Notification from Shenzhen CosBeauty Technology Co., Ltd. to the FDA for their LLLT Laser Hair Growth Cap. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.
Absence of Clinical Study for Device Acceptance Criteria
Critically, the provided document does not report any clinical study data or acceptance criteria related to the device's efficacy in promoting hair growth. The submission focuses on demonstrating substantial equivalence to a predicate device (CAPOGEN Laser Cap, K201854) and a reference device (Lasercap Family of Lasers, K203826) primarily through non-clinical testing and comparison of technical specifications.
The provided text explicitly states in section (9) "Non-clinical studies and tests performed" and section (10) "Conclusion" that non-clinical testing was conducted to verify compliance with design specifications and safety standards. There is no mention of a clinical trial, performance study, or any data proving the device meets specific efficacy-related acceptance criteria for hair growth.
Therefore, I cannot provide information on:
- A table of acceptance criteria and the reported device performance: No performance criteria for hair growth are stated, nor is performance data presented.
- Sample size used for the test set and data provenance: No clinical test set is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a clinical test set is mentioned.
- Adjudication method for the test set: No clinical test set is mentioned.
- If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: No such study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
- The type of ground truth used: No ground truth for clinical efficacy is mentioned.
- The sample size for the training set: Not applicable as no AI algorithm or training set for clinical efficacy is mentioned.
- How the ground truth for the training set was established: Not applicable.
What the document does describe are safety and performance standards for the device itself (e.g., electrical safety, biocompatibility, laser classification) and a comparison of its technical specifications to predicate devices to establish substantial equivalence.
The "Acceptance Criteria" for this 510(k) submission are therefore implied to be the successful demonstration of:
- Substantial Equivalence: The subject device (LLLT Laser Hair Growth Cap) is as safe and effective as a legally marketed predicate device, as determined by technical comparison and non-clinical testing.
- Compliance with Recognized Standards: The device meets applicable national and international consensus standards for medical electrical equipment, laser safety, and biocompatibility.
Here's what can be extracted regarding the device and its assessment:
Device Acceptance Criteria (Implied for 510(k) Substantial Equivalence and Safety):
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance / Compliance |
|---|---|---|
| I. Substantial Equivalence (Overall) | The device is as safe, as effective, and performs as well as the legally marketed predicate device (K201854, CAPOGEN Laser Cap). Its indications for use, technological characteristics, and treatment parameters are similar to the predicate and reference devices. | The document concludes that "LLLT Laser Hair Growth Cap is substantially equivalent to the predicate device" based on a detailed comparison of features, similar indications for use, and compliance with similar safety and performance standards. |
| II. Electrical Safety | Compliance with ANSI AAMI ES 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance). | "Non-clinical testings have been conducted to verify... complies with... ANSI AAMI ES 60601-1." |
| III. Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests). | "Non-clinical testings have been conducted to verify... complies with... IEC 60601-1-2." |
| IV. Home Healthcare Environment Safety | Compliance with 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). | "Non-clinical testings have been conducted to verify... complies with... IEC 60601-1-11." |
| V. Laser Safety Classification | Compliance with IEC 60825-1 (Safety of laser products - Part 1: Equipment classification, and requirements) resulting in a Class 3R laser classification. | "Testing to IEC 60825-1 certifies the laser system to classification 3R, which is the same as the predicate device." |
| VI. Biocompatibility | Compliance with ISO 10993-5 (Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity) and ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization) for all body-contacting materials. | "The device has been tested for biocompatibility, it complies with the following standards: ISO 10993-5 [and] ISO 10993-10." |
| VII. Software Verification & Validation | Compliance with FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices." | "Software verification and validation test according to the requirements of the FDA 'Guidance for Pre Market Submissions and for Software Contained in Medical Devices.'" |
| VIII. Lithium Battery Safety | Compliance with IEC 62133 (for lithium battery). | "the lithium battery of the subject device has passed IEC62133 test." |
| IX. Power Adapter Safety | Assessed for electrical safety along with the main unit. | "the power adapter has been assessed for electrical safety test along with the main unit." |
Study Information (Non-Clinical):
- Sample Size for Test Set and Data Provenance: Not applicable for clinical efficacy. For non-clinical studies, the "sample size" would refer to the number of devices or components tested. This is not explicitly stated but implied to be sufficient for compliance testing. The provenance is Shenzhen, China (manufacturer location) and third-party labs. All studies are presumably prospective for the purpose of this 510(k) submission.
- Number of Experts and Qualifications: Not applicable for establishing "ground truth" for clinical efficacy. Experts would be involved in designing and conducting the non-clinical tests (e.g., electrical engineers, toxicologists), but their specific number and qualifications are not detailed in this summary.
- Adjudication Method: Not applicable for clinical efficacy. For non-clinical tests, results are typically assessed against pre-defined thresholds or criteria in the respective standards.
- MRMC Comparative Effectiveness Study: Not done.
- Standalone Performance (Algorithm): Not applicable; this is a physical LLLT device, not an AI algorithm.
- Type of Ground Truth: For the non-clinical studies, the "ground truth" refers to the established technical standards (e.g., IEC, ISO) and the measurable properties of the device (e.g., electrical output, laser wavelength, material cytotoxicity).
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set was Established: Not applicable.
Conclusion:
The K213447 submission is a premarket notification based on demonstrating "substantial equivalence" of the LLLT Laser Hair Growth Cap to an existing legally marketed device. This pathway generally relies on demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The "studies" referenced are non-clinical bench tests and comparisons against recognized standards to ensure the device's safety and fundamental performance characteristics are equivalent to the predicate. There is no reported clinical study in this document to prove the device meets specific acceptance criteria for hair growth efficacy itself. The efficacy is implicitly accepted based on the predicate device's prior clearance and the similarity of the technology.
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January 19, 2022
Shenzhen CosBeauty Technology Co., Ltd. % Tracy Che Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road, Shenzhen, Guangdong 518052 China
Re: K213447
Trade/Device Name: LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: October 18, 2021 Received: October 25, 2021
Dear Tracy Che:
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.
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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) 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,
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213447
Device Name
LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
Indications for Use (Describe)
LLLT Laser Hair Growth 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
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information:
| 510(k) owner's name: | Shenzhen CosBeauty Technology Co., Ltd. |
|---|---|
| Address: | UnitA-3F, Qiao De Industrial Park, Tian Liao Guang Ming District,Shenzhen, China |
| Contact person: | Ares Zou |
| Phone number: | +86 755 8627 1293 |
| Fax number: | +86 755 8629 0505 |
| Email: | zougaofeng@cos-beauty.com |
| Date of summary prepared: | 2021-10-18 |
(2) Reason for the submission
New device, there were no prior submissions for the device.
(3) Proprietary name of the device
| Trade name/model: | LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210 |
|---|---|
| Common name: | Lamp, non-heating, for promotion of hair growth |
| Regulation number: | 21 CFR 890.5500 |
| Product code: | OAP |
| Review panel: | General & Plastic Surgery |
| Regulation class: | Class II |
(4) Predicate and reference device
Predicate device >
| Sponsor | Nature Incredible Inc. |
|---|---|
| Device Name and Model | CAPOGEN Laser Cap, model: CG-148, CG-272 |
| 510(k) Number | K201854 |
| Product Code | OAP |
| Regulation Number | 21 CFR 890.5500 |
| Regulation Class | II |
| Reference device | |
| Sponsor | Transdermal Cap, Inc. |
| Device Name and Model | Lasercap Family of Lasers, Models 300, 224, 120 and 80 |
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| 510(k) Number | K203826 |
|---|---|
| Product Code | OAP |
| Regulation Number | 21 CFR 890.5500 |
| Regulation Class | II |
(5) Description/ Design of device:
LLLT Laser Hair Growth 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 visible red light-emitting diodes at 650mm and 5mW each. LLLT Laser Hair Growth Cap includes three models, Hair Care 210, Hair Care 135 and Hair Care 210 (210 diodes) is the typical model, Hair Care 135 (135 diodes) and Hair Care 88 (88 diodes) are exactly the same as the Hair Care 210 regarding structure design, intended use, performance and operation, with the difference being the diode amount. Each model has three colors, which are white, hidden color and pool blue.
(6) Indications for use:
LLLT Laser Hair Growth 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.
(7) Materials
| Componentname | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| LLLT LaserHair GrowthCap (mainunit+gasket) | PA6/PC/PVC | Surface-contactingdevice: Intact skin | Less than 24 hours |
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to "Biocompatibility Discussion".
(8) Technological characteristics and substantial equivalence:
| Item | Subject device | Predicate device | Reference device | Remark |
|---|---|---|---|---|
| Trade name | LLLT Laser Hair Growth Cap, model:Hair Care 88, Hair Care135, Hair Care 210 | CAPOGEN LaserCap, model: CG-148,CG-272 | Lasercap Family ofLasers, Models 300,224, 120 and 80 | / |
| 510 (k) number | To be assigned | K201854 | K203826 | / |
| Manufacturer | Shenzhen CosBeauty | Nature Incredible Inc. | Transdermal Cap, Inc. | / |
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| Technology Co., Ltd. | ||||
|---|---|---|---|---|
| Regulation number | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 | Same |
| Regulation description | Infrared lamp | Infrared lamp | Infrared lamp | Same |
| Product code | OAP | OAP | OAP | Same |
| Class | II | II | II | Same |
| Indications for use/ Intended use | LLLT Laser Hair Growth 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. | CAPOGEN Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa | Promoting hair growth in females with Androgenetic Alopecia who have Ludwig -Savin Classifications of I-II and males who have Norwood-Hamilton Classifications of Ila - V and for both, Fitzpatrick Classifications of Skin Phototypes of I-IV. | Same |
| Location for use | OTC | OTC | OTC | Same |
| Power supply | DC5V-1A, 3500mAH lithium battery | DC5V, 2A | / | DifferentNote 1 |
| Type of light | Visible red light-emitting diodes | Visible red light-emitting diodes | Laser diode | Same |
| Wavelength | 650nm ± 10nm | 650nm | 650nm ± 5nm | Similar |
| Amount of laser diodes | Hair Care 88: 88Hair Care 135:135Hair Care 210: 210 | CG-148: 148CG-272: 272 | 300, 224, 120, 80 | DifferentNote 2 |
| Energy per laser diode | 5mW ±20% | 5mW | 5mW | Similar |
| Laser classification according to IEC60825-1 | Class 3R | Class 3R | Class 3R | Same |
| Treatment time | Each treatment: 30min16 weeks, every other day (indefinite) | Each treatment:30min16 weeks, every other day (indefinite) | 16 weeks, for 30-minute treatment times three times a week, on alternate days | Same |
| Applicablepeople | Norwood-HamiltonIIa~V (males)Ludwig-Savin(females) | Norwood-HamiltonIIa | Norwood-HamiltonIIa | Same |
| Applicable skin | FitzpatrickPhototypes I-IV | FitzpatrickPhototypes I-IV | FitzpatrickPhototypes I-IV | Same |
| Helmet/Capdesign | Yes | Yes | Yes | Same |
| Dimensions | 179.6211.4104.4mm | (LWH)CG-148:22189cmCG-272:22189cm | / | DifferentNote 3 |
| Weight | Hair Care 88: 358g;Hair Care 135: 368g;Hair Care 210: 398g | CG-148: 0.26kgCG-272: 0.26kg | / | DifferentNote 3 |
| Environmentfor operation | Temperature: 5 °C ~30°C;Humidity: ≤80%; | Temperature: 10 °C | / | Similar |
| Environmentfor storage | Temperature: 0 °C ~55°C;Humidity: ≤93%; | Temperature: -10 °C | / | Similar |
| Compliancewith voluntarystandards | IEC 60601-1;IEC 60601-1-2;IEC 60601-1-11;IEC 60825-1;IEC 62133(lithium battery) | Complied withIEC60601-1,IEC60601-1-11,IEC60601-1-2 andIEC60825-1Complied withIEC62133(Battery pack)Complied withIEC60950 (Adapter) | IEC 60601-1;IEC 60601-1-2;IEC 60601-1-11;IEC 60825-1 | Same |
| Biocompatibility feature | All body-contactingmaterials are compliedwith ISO10993-5 andISO 10993-10 | All body-contactingmaterials arecomplied withISO10993-5 and ISO10993-10 | All body-contactingmaterials are compliedwith ISO10993-5 andISO 10993-10 | Same |
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Comparison in details:
Note 1:
The power supply for the subject device is different from that of the predicate device, however the lithium battery of the subject device has passed IEC62133 test and the power adapter has been assessed for electrical safety test along with the main unit, so this difference should not raise any safety/effectiveness questions.
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Note 2:
The number of diodes are defined by the manufacturer, although it's different from that of the predicate device, it's similar and within the range of the reference device. Since as 80 diodes with similar parameters of 650mm ± 5nm wavelength and 5mW energy per diode are demonstrated to be effective, 88, 135, 210 diodes should also be effective. This difference should not raise any safety/effectiveness questions.
Note 3:
Although the appearance, weight and dimensions are different between the subject and predicate device, these differences are insignificant and do not raise any safety/effectiveness problems.
Conclusion:
LLLT Laser Hair Growth Cap is substantially equivalent to the predicate device.
(9) Non-clinical studies and tests performed:
Non-clinical testings have been conducted to verify that the LLLT Laser Hair Growth Cap meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device complies with the following standards:
- A ANSI AAMI ES 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- A 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
- A IEC 60825-1, Safety of laser products - Part 1: Equipment classification, and requirements Testing to IEC 60825-1 certifies the laser system to classification 3R, which is the same as the predicate device.
The device has been tested for biocompatibility, it complies with the following standards.
- A ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
We have also conducted:
- A Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
(10) Conclusion
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Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device LLLT Laser Hair Growth Cap is as safe, as effective, and performs as well as the legally marketed predicate device, K201854, CAPOGEN Laser Cap, model: CG-148, CG-272.
§ 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.