(86 days)
No
The device description and performance studies focus on the physical properties of the laser therapy and compliance with electrical and laser safety standards. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications.
Yes
The device is intended to promote hair growth in individuals with androgenic alopecia, which is a medical condition, making its purpose therapeutic.
No
The "Intended Use" states that the device is "indicated to promote hair growth," not to diagnose a condition. The "Device Description" also clarifies that it is "designed to promote hair growth."
No
The device description clearly states it is a "dome-shaped low level laser therapy (LLLT) device" with "visible red light-emitting diodes," indicating it is a hardware device. The performance studies also include testing for electrical safety, laser safety, and biocompatibility, which are relevant to hardware components. While software verification and validation were performed, this is for software contained in the medical device, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "promote hair growth in males and females with androgenic alopecia." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a "low level laser therapy (LLLT) device designed to promote hair growth." It uses light to stimulate a biological process, not to analyze a sample from the body.
- Lack of Diagnostic Activity: There is no mention of the device analyzing blood, tissue, or any other sample from the body to provide diagnostic information.
- Performance Studies: The performance studies focus on safety, electrical standards, biocompatibility, and software validation, which are typical for therapeutic devices, not IVDs. The studies do not involve evaluating the device's ability to diagnose a condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such a function.
N/A
Intended Use / 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.
Product codes
OAP
Device Description
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.
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
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
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"
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
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
| Component
| name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| LLLT Laser | |||
| Hair Growth | |||
| Cap (main | |||
| unit+gasket) | PA6/PC/PVC | Surface-contacting | |
| device: 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 Care | ||||
| 135, Hair Care 210 | CAPOGEN Laser | |||
| Cap, model: CG-148, | ||||
| CG-272 | Lasercap Family of | |||
| Lasers, 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 | / | Different |
| Note 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: 88 | |||
| Hair Care 135:135 | ||||
| Hair Care 210: 210 | CG-148: 148 | |||
| CG-272: 272 | 300, 224, 120, 80 | Different | ||
| Note 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: 30min | |||
| 16 weeks, every other day (indefinite) | Each treatment: | |||
| 30min | ||||
| 16 weeks, every other day (indefinite) | 16 weeks, for 30-minute treatment times three times a week, on alternate days | Same | ||
| Applicable | ||||
| people | Norwood-Hamilton | |||
| IIa~V (males) | ||||
| Ludwig-Savin | ||||
| (females) | Norwood-Hamilton | |||
| IIa~V (males) | ||||
| Ludwig-Savin I~II | ||||
| (females) | Norwood-Hamilton | |||
| IIa~V (males) | ||||
| Ludwig-Savin I~II | ||||
| (females) | Same | |||
| Applicable skin | Fitzpatrick | |||
| Phototypes I-IV | Fitzpatrick | |||
| Phototypes I-IV | Fitzpatrick | |||
| Phototypes I-IV | Same | |||
| Helmet/Cap | ||||
| design | Yes | Yes | Yes | Same |
| Dimensions | 179.6211.4104.4mm | (LWH) | ||
| CG-148:22189cm | ||||
| CG-272:22189cm | / | Different | ||
| Note 3 | ||||
| Weight | Hair Care 88: 358g; | |||
| Hair Care 135: 368g; | ||||
| Hair Care 210: 398g | CG-148: 0.26kg | |||
| CG-272: 0.26kg | / | Different | ||
| Note 3 | ||||
| Environment | ||||
| for operation | Temperature: 5 °C ~ | |||
| 30°C; | ||||
| Humidity: ≤80%; | Temperature: 10 °C ~ | |||
| 30°C | ||||
| (50°F~86°F) | ||||
| Humidity: 20%~80% | / | Similar | ||
| Environment | ||||
| for storage | Temperature: 0 °C ~ | |||
| 55°C; | ||||
| Humidity: ≤93%; | Temperature: -10 °C ~ | |||
| 60°C | ||||
| (14°F~140°F) | ||||
| Humidity: 20%~80% | / | Similar | ||
| Compliance | ||||
| with voluntary | ||||
| standards | IEC 60601-1; | |||
| IEC 60601-1-2; | ||||
| IEC 60601-1-11; | ||||
| IEC 60825-1; | ||||
| IEC 62133 | ||||
| (lithium battery) | Complied with | |||
| IEC60601-1, | ||||
| IEC60601-1-11, | ||||
| IEC60601-1-2 and | ||||
| IEC60825-1 | ||||
| Complied with | ||||
| IEC62133 | ||||
| (Battery pack) | ||||
| Complied with | ||||
| IEC60950 (Adapter) | IEC 60601-1; | |||
| IEC 60601-1-2; | ||||
| IEC 60601-1-11; | ||||
| IEC 60825-1 | Same | |||
| 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 | Same |
6
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.
7
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.