(57 days)
No
The device description focuses on low-level laser therapy (LLLT) using LEDs and does not mention any AI/ML components or functionalities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device's intended use is to "promote hair growth in males with androgenic alopecia" and "females with androgenic alopecia," which describes treatment for a medical condition.
No
The device description indicates its purpose is to "promote hair growth," and the intended use specifies it is "indicated to promote hair growth." There are no mentions of using the device to identify, detect, monitor, or diagnose any medical condition.
No
The device description clearly states it is a "dome-shaped low level laser therapy (LLLT) device" with "visible red light-emitting diodes" and is "powered by an included battery pack," indicating it is a physical hardware 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" by applying light therapy to the scalp. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a laser cap that emits light. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.), which is a key characteristic of IVDs.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's condition.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device's purpose is to treat hair loss, not to diagnose it or any underlying condition.
N/A
Intended Use / Indications for Use
CAPOGEN Laser 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
The CG-272 CAPOGEN Laser 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 272visible red light-emitting diodes at 650mm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner (containing the electronics and laser array) and is powered by an included battery pack. The CG-148 CAPOGEN Laser Cap is exactly the same as the CG-272 with the exception of the number of diodes which is respective of model (148 diodes in CG-148).
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
OTC application
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)
The following performance data were provided in support of the substantial equivalence determination.
1)Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the CAPOGEN Laser Cap was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:
- ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization
2)Electrical and EMC Safety
Electrical safety and EMC safety testing was performed to, and passed, the following standards:
- IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- 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
- 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
In addition, testing to IEC 60825-1 certifies the laser system to classification 3R, which is the same as the predicate devices. And the charger conforms to IEC 60950 and the battery to IEC 62133.
Summary
Based on the above performance as documented in this application. CAPOGEN Laser Cap was found to have a safety and effectiveness profile that is same as the predicate device.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
September 1, 2020
Nature Incredible Inc % Gamma Zhang RA Manager Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg. 1, Southward Ruifeng Business Center Guimiao Road Shenzhen, Guangdong 518000 China
Re: K201854
Trade/Device Name: CAPOGEN Laser Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: July 6, 2020 Received: July 6, 2020
Dear Gamma Zhang:
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.
1
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 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
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Indications for Use
510(k) Number (if known) K201854
Device Name CAPOGEN Laser Cap, Model: CG-148, CG-272
Indications for Use (Describe)
CAPOGEN Laser 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
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: 2020-06-28
I. Submitter
Nature Incredible Inc. 3422 OLD CAPITOL TRAIL #569 WILMINGTON, DELAWARE 19808 Tel.: (508) 276-5155
John Lee (General Manager) Tel: (508) 276-5155 Email: natureincredibleinc@gmail.com
II. Device
Type of 510(k): Traditional Common Name: Lamp, non-heating, for promotion of hair growth Trade Name: CAPOGEN Laser Cap, Model: CG-148, CG-272 Classification Name: Infrared lamp per 21 CFR 890.5500 Review Panel: General & Plastic Surgery Regulatory Class: II Product Code: OAP Regulation Number: 21 CFR 890.5500
III. Predicate Device
| Applicant | Predicate Device | 510(k) Number |
|---|---|---|
| Cosmo Far East | ||
| Technology Limited | Diode Laser Cap | K173678 |
IV. Device Description
The CG-272 CAPOGEN Laser 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 272visible red light-emitting diodes at 650mm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner (containing the electronics
4
and laser array) and is powered by an included battery pack. The CG-148 CAPOGEN Laser Cap is exactly the same as the CG-272 with the exception of the number of diodes which is respective of model (148 diodes in CG-148).
V. Indications for Use
CAPOGEN Laser 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.
VI. Comparison of Technological Characteristics With the Predicate Device
The CAPOGEN Laser Cap and predicate device Diode Laser Cap is the same product, and they only differ from trade name.
The CAPOGEN Laser Cap raises no safety or efficacy concerns when compared to the predicate devices.
| Comparison
| Elements | Subject Device | Predicate Device |
|---|---|---|
| K Number | Pending | K173678 |
| Trade name | CAPOGEN Laser Cap | Diode Laser Cap |
| Model | CG-148 | |
| CG-272 | COSMO-020 | |
| COSMO-030 | ||
| Classification | ||
| name | Infrared Lamp | Infrared Lamp |
| Product code | OAP | OAP |
| Intended | ||
| use/Indications | CAPOGEN Laser 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 to IV. | Diode Laser 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 to IV. | ||
| Location for use | OTC application | OTC application |
| Type of Light | Visible red light-emitting diodes | Visible red light-emitting diodes |
| Wavelength | 650nm | 650nm |
| Amount of laser | ||
| diodes | CG-148: 148 | |
| CG-272: 272 | COSMO-020: 148 | |
| COSMO-030: 272 | ||
| Energy of per | ||
| laser diode | 5mW | 5mW |
| Classification | ||
| according to | ||
| IEC60825-1 | Class 3R | Class 3R |
| Comparison | ||
| Elements | Subject Device | Predicate Device |
| Treatment time | Each treatment: 30min | |
| 16 weeks, every other day (indefinite) | Each treatment: 30min | |
| 16 weeks, every other day (indefinite) | ||
| Applicable people | Norwood-Hamilton IIa~V (males) | |
| Ludwig-Savin I~II (females) | Norwood-Hamilton IIa~V (males) | |
| Ludwig-Savin I~II (females) | ||
| Applicable skin | Fitzpatrick Skin Phototypes I-IV | Fitzpatrick Skin Phototypes I-IV |
| Helmet/Cap | ||
| design | Yes | Yes |
| Dimension | (LWH) | |
| CG-148:22189cm CG- | ||
| 272:22189cm | (LWH) | |
| COSMO-020:22189cm | ||
| COSMO-030: 22189cm | ||
| Weight | CG-148: 0.26kg | |
| CG-272: 0.26kg | COSMO-020: 0.26kg | |
| COSMO-030: 0.26kg | ||
| Environment | ||
| for | ||
| operation | Temperature: 10℃~30℃ | |
| (50°F~86°F) | ||
| Humidity: 20%~80% | Temperature: 10℃~30℃ | |
| (50°F~86°F) | ||
| Humidity: 20%~80% | ||
| Environment | ||
| for | ||
| storage | Temperature: -10°C~60°C | |
| (14°F~140°F) | ||
| Humidity: 20%~80% | Temperature: -10℃~60℃ | |
| (14°F~140°F) | ||
| Humidity: 20%~80% | ||
| Safety feature | Complied with IEC60601-1, | |
| IEC60601-1-11, IEC60601- | ||
| 1-2 and IEC60825-1 | ||
| Complied with IEC62133 | ||
| (Battery pack) | ||
| Complied with IEC60950 | ||
| (Adapter) | Complied with IEC60601-1, | |
| IEC60601-1-11, IEC60601- | ||
| 1-2 and IEC60825-1 | ||
| Complied with IEC62133 | ||
| (Battery pack) | ||
| Complied with IEC60950 | ||
| (Adapter) | ||
| Biocompatibility | ||
| feature | All body-contacting | |
| materials are complied with | ||
| ISO10993-5 and ISO 10993- |
-
| All body-contacting
materials are complied with
ISO10993-5 and ISO 10993-
10. |
A technical comparison to the predicate is provided below:
5
6
VII.Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1)Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the CAPOGEN Laser Cap was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:
-
ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization
2)Electrical and EMC Safety
Electrical safety and EMC safety testing was performed to, and passed, the following standards:
-
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
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
-
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
In addition, testing to IEC 60825-1 certifies the laser system to classification 3R, which is the same as the predicate devices. And the charger conforms to IEC 60950 and the battery to IEC 62133.
Summary
Based on the above performance as documented in this application. CAPOGEN Laser Cap was found to have a safety and effectiveness profile that is same as the predicate device.
VIII. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the CAPOGEN Laser Cap is to be concluded same to its predicate devices.