(90 days)
Diode 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.
The COSMO-030 and COSMO-010 Diode 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 650nm 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 COSMO-020 Diode Laser Cap is exactly the same as the COSMO-030 with the exception of the number of diodes which is respective of model (148 diodes in COSMO-020).
The provided text is a 510(k) Summary for the Diode Laser Cap. It focuses on demonstrating substantial equivalence to predicate devices, primarily through a comparison of technical characteristics and compliance with safety and biocompatibility standards. It does not contain information about acceptance criteria or a study proving the device meets those criteria in terms of efficacy for hair growth, nor does it discuss AI performance or ground truth establishment.
Therefore, I cannot provide the detailed information requested in the prompt based on the given text.
However, I can extract and state what information is present:
1. A table of acceptance criteria and the reported device performance:
The document presents a comparison of technological characteristics with predicate devices to establish substantial equivalence, rather than specific acceptance criteria for a performance study. No quantitative efficacy criteria for hair growth or reported performance against such criteria are provided. The performance data presented are for safety and biocompatibility.
| Criterion (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| In Vitro Cytotoxicity (ISO 10993-5) | Passed |
| Irritation & Skin Sensitization (ISO 10993-10) | Passed |
| Electrical & EMC Safety: | |
| Basic Safety & Essential Performance (IEC 60601-1) | Passed |
| Home Healthcare Environment (IEC 60601-1-11) | Passed |
| Electromagnetic Compatibility (IEC 60601-1-2) | Passed |
| Laser Classification: | |
| IEC 60825-1 (Laser System) | Complied with Class 3R |
| Charger Safety: | |
| IEC 60950 | Conforms |
| Battery Safety: | |
| IEC 62133 | Complied with |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information is provided regarding sample sizes or data provenance for any hair growth efficacy study. The document only references testing for biocompatibility, electrical safety, and EMC, which are typically performed on device components or the device itself, not human subjects for efficacy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The document does not describe any test set for hair growth efficacy where expert ground truth would be established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set for hair growth efficacy is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a laser cap for hair growth, not an AI software intended for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a hardware product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable for hair growth efficacy from the provided document. The "ground truth" for the safety and biocompatibility tests would be the pass/fail criteria defined by the respective international standards.
8. The sample size for the training set:
Not applicable. The document does not describe any AI component or a training set.
9. How the ground truth for the training set was established:
Not applicable. The document does not describe any AI component or a training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 28, 2018
Cosmo Far East Technology Limited % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road Shenzhen, 518000 Cn
Re: K173678
Trade/Device Name: Diode Laser Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: November 21, 2017 Received: November 30, 2017
Dear Rain Yip:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm_for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -
S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Diode Laser Cap /(Model: COSMO-030, COSMO-020, COSMO-010)
Indications for Use (Describe)
Diode 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: 2017.11.21
I. Submitter
Cosmo Far East Technology Limited Room 1504, Building 1, XingJiJia Yuan, Bao'an Avenue, Songgang, Bao'an District, Shenzhen, Guangdong, China
Tel.: +86 755 2321 0240 Tax: +86 755 2321 0240
Bob An (General Manager) Tel: +86 189 1115 3013 Email: cosmobeautylaser@126.com
II. Device
Type of 510(k): Traditional Common Name: Lamp, non-heating, for promotion of hair growth Trade Name: Diode Laser Cap 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
-
- Predicate device
| Applicant | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| EGlobal, LLC | illumiflow Laser Cap | K162071 | Feb.24. 2017 |
| Capillus, LLC | Capillus laser domes | K163170 | Jan.31, 2017 |
- Reference device: None
IV. Device Description
The COSMO-030 and COSMO-010 Diode 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 650nm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner (containing the electronics
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and laser array) and is powered by an included battery pack. The COSMO-020 Diode Laser Cap is exactly the same as the COSMO-030 with the exception of the number of diodes which is respective of model (148 diodes in COSMO-020).
V. Indications for Use
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-IV.
VI. Comparison of Technological Characteristics With the Predicate Device
The Diode Laser Cap is substantially equivalent to the predicated device based on intended use, design, specifications and performance.
The Diode Laser Cap raises no safety or efficacy concerns when compared to the predicate devices.
Information for predicate device was obtained from publicly available sources, including the 510(k) Summary and device instruction manual. A technical comparison to the predicate is provided below:
| ComparisonElements | Subject Device | Predicate Device 1 | Predicate Device 2 |
|---|---|---|---|
| K Number | Pending | K162071 | K161370 |
| Trade name | Diode Laser Cap | illumiflow Laser Cap | Capillus laser domes |
| Classification name | Infrared Lamp | Infrared Lamp | Infrared Lamp |
| Product code | OAP | OAP | OAP |
| Intendeduse/IndicationsforUse | Diode Laser Cap isindicated to promotehair growth in maleswith androgenicalopecia who haveNorwood-Hamiltonclassifications ofIIa | The illumiflow LaserCap is indicated topromote hair growthin males withandrogenic alopeciawho have Norwood-Hamiltonclassifications ofIIa | The Capillus laserdomes 82, 202, 272Pro, 272 OfficePro,302, 312, and 352, areintended to treatAndrogeneticAlopecia and promotehair growth in maleswho have NorwoodHamiltonClassifications of IIato V patterns of hairloss and to treatAndrogeneticAlopecia and promotehair growth in females |
| ComparisonElements | Subject Device | Predicate Device 1 | Predicate Device 2 |
| who have Ludwig(Savin) Scale I-1 to I-4, II-1, II-2, or frontal;both with FitzpatrickSkin Types I to IV. | |||
| Location for use | OTC application | OTC application | OTC application |
| Type of Light | Visible red light-emitting diodes | Visible red light-emitting diodes | Visible red light-emitting diodes |
| Wavelength | 650nm | 650nm | 650nm |
| Amount of laserdiodes | COSMO-010: 272COSMO-020: 148COSMO-030: 272 | 272 | Capillus 82: 82Capillus 202: 202Capilus 272 Pro: 272 |
| Energy of per laserdiode | 5mW | 5mW | 5mW |
| ClassificationaccordingtoIEC60825-1 | Class 3R | Class 3R | Class 3R |
| Treatment time | Each treatment: 30min16 weeks, every otherday (indefinite) | Each treatment: 30min16 weeks, every otherday (indefinite) | Each treatment: 30min17 weeks, every otherday (indefinite) |
| Applicable people | Norwood-HamiltonIIa~V (males) | Norwood-HamiltonIIa~V (males) | Norwood-HamiltonIIa~V (males) |
| Ludwig-Savin I~II(females) | Ludwig-Savin I~II(females) | Ludwig-Savin I~II orfrontal (females) | |
| Applicable skin | Fitzpatrick SkinPhototypes I-IV | Fitzpatrick SkinPhototypes I-IV | Fitzpatrick SkinPhototypes I-IV |
| Helmet/Cap design | Yes | Yes | Yes |
| Dimension | (LWH)COSMO-010:23189cmCOSMO-020:22189cmCOSMO-030: | Perimeter: 61cmDiameter: 19cm | Unknown |
| ComparisonElements | Subject Device | Predicate Device 1 | Predicate Device 2 |
| 22189cm | |||
| Weight | COSMO-010: 0.22kgCOSMO-020: 0.26kgCOSMO-030: 0.26kg | 0.22kg | Unknown |
| Environmentforoperation | Temperature: 10 °C | Temperature: -10 °C | Temperature: 5 °C |
| Environmentforstorage | Temperature: -10 °C | Temperature: -10 °C | Unknown |
| Safety feature | Complied withIEC60601-1,IEC60601-1-11,IEC60601-1-2 andIEC60825-1Complied withIEC62133 (Batterypack)Complied withIEC60950 (Adapter) | Complied withIEC60601-1,IEC60601-1-2 andIEC60825-1Complied withIEC62133 (Battery)Complied withIEC60950 (Charger) | Complied withIEC60825-1Complied withIEC60950 (Charger) |
| Biocompatibilityfeature | All body-contactingmaterials are compliedwith ISO10993-5 andISO 10993-10. | All body-contactingmaterials are compliedwith ISO10993-5 andISO 10993-10. | All body-contactingmaterials are compliedwith ISO10993-5 andISO 10993-10. |
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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 Diode Laser Cap was conducted in accordance with the "Use of International Standard ISO 10993-1, "Biological
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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, Diode Laser Cap was found to have a safety and effectiveness profile that is similar to 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 Diode Laser Cap is to be concluded substantial equivalent to its predicate devices.
§ 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.