(233 days)
No
The summary describes a low-level laser device for hair growth and mentions standard electrical, EMC, biocompatibility, and software testing. There is no mention of AI, ML, image processing, or data sets for training/testing AI/ML models.
Yes
The device is intended for the promotion of hair growth in individuals with androgenic alopecia, which addresses a medical condition.
No
The device is intended for the promotion of hair growth in individuals with androgenic alopecia, which is a therapeutic function rather than a diagnostic one. It does not analyze conditions or provide insights into a disease state.
No
The device description explicitly states it is a "low-level laser device" consisting of "red visible light diode lasers" arranged in a "dot matrix arrangement in the inner of the helmet." This indicates the device is a hardware product that utilizes lasers for its intended use, not solely software. The software verification and validation mentioned are likely for controlling the hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "promotion of hair growth" by applying light to the scalp. This is a therapeutic or cosmetic application, not a diagnostic one.
- Device Description: The device uses lasers to stimulate hair follicles. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or functions related to in vitro testing, sample analysis, or diagnostic interpretation.
- Performance Studies: The performance studies focus on safety (electrical, EMC, biocompatibility) and software validation, which are typical for medical devices but not specifically for IVDs, which would require studies demonstrating analytical and clinical performance related to a diagnostic claim.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Laser hair growth helmet (Model: A-800) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.
Product codes
OAP
Device Description
The Laser hair growth helmet (Model: A-800) is hands-free, portable, non-invasive, low-level laser device, which consists of red visible light diode lasers, to produce red light operating at 650nm wavelength (maximum output power of each is 5mW). The laser sources are arranged in a dot matrix arrangement in the inner of the helmet, which could take into account of every hair follicle and promote rapid hair growth. The device will automatically suspend the work if it is removed from scalp, and the power blue light indicator flashes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
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)
Clinical performance is not deemed necessary.
The Laser hair growth helmet has been evaluated for its safety and performance by lab bench testing as following:
- Electrical safety and performance test according to IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD) and IEC 60825-1:2014 Safety of laser products - Part 1 : Equipment classification and requirements|Including: Technical Corrigendum 1 (2008) Interpretation Sheet 1 (2007) Interpretation Sheet 2 (2007)]
- Electromagnetic compatibility test according to IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- Biocompatibility test according to ISO 10993-5:2009 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity and ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- Software verification and validation test according to the requirements of the FDA "Guidance for Premarket Submissions and for Software Contained in Medical Devices’
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 12, 2022
Kam Yuen Plastic Products Ltd. % Jett Lee Regulation Manager Guangdong Jianda Medical Technology Co Ltd 906 Room, Longxiang Garden, Tianhe District Guangzhou, Guangdong China
Re: K213025
Trade/Device Name: Laser hair growth helmet Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: April 9, 2022 Received: April 12, 2022
Dear Jett 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.
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 mediation-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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213025
Device Name Laser hair growth helmet (Model: A-800)
Indications for Use (Describe)
The Laser hair growth helmet (Model: A-800) is intended for the prowth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Date of the summary prepared: May 11, 2022
510(k) Summary
510(k) number: K213025
Thissummary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. This is a traditional 510(K) submission with no previous application.
1. Submitter's Information
Sponsor
- � Company Name: Kam Yuen Plastic Products Ltd.
- Address: No. 2, Hengfeng 2nd Road, Pujin Industrial , Konghou Town, Zhongshan City, � Guangdong Province, China Phone: 86- 400- 962- 1668 Fax: 86-0760-8841-3080
- Contact Person (including title): Anna Dan (Manager) �
- E-mail: kamyuen@kyplastic.com �
Application Correspondent:
Guangdong Jianda Medical Technology Co Ltd Address: 906 Room, Longxiang Garden, Tianhe district, Guangzhou, China Contact Person: Mr. Jett Lee Title: Regulation Manager Tel: +86-13512755282 Email: jianda-lee@foxmail.com
2. Subject Device Information
- � Trade Name: Laser hair growth helmet
- Model: A-800 �
- Common Name: Laser, comb, hair �
- Classification name: Infrared lamp per 21 CFR 890.5500 �
- Review Panel: General & Plastic Surgery �
- Product Code: OAP �
4
- Requlation Class: 2 �
- � Regulation Number: 21 CFR 890.5500
3. Predicate Device Information
| Predicate Device I | Predicate Device II | Reference Device | |
|---|---|---|---|
| 510(k) Number | K193008 | K190467 | K173678 |
| Device | |||
| Name | Tricoglam Home Use | iHelmet Hair Grow th | |
| System | Diode Laser Cap | ||
| Product Code | OAP | OAP | OAP |
| Regulation | |||
| Number | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 |
| Regulation | |||
| Class | 2 | 2 | 2 |
2. Device Description
The Laser hair growth helmet (Model: A-800) is hands-free, portable, non-invasive, low-level laser device, which consists of red visible light diode lasers, to produce red light operating at 650nm wavelength (maximum output power of each is 5mW). The laser sources are arranged in a dot matrix arrangement in the inner of the helmet, which could take into account of every hair follicle and promote rapid hair growth. The device will automatically suspend the work if it is removed from scalp, and the power blue light indicator flashes.
3. Indications for Use
The Laser hair growth helmet (Model: A-800) is intended for the promotion of hair growth in females with androgenic alopedia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Cla-V; and both genders having Fitzpatick Classification of Skin Phototypes I-IV.
বা Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, and intended use of Laser hair growth helmet, model: A-800 is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
5
Sponsor: Kam Yuen Plastic Products Ltd. Laser hair growth helmet, Model: A-800 Subject Device: File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary
| Substantial Equivalence Comparison Table for
| A-800 | ||||
|---|---|---|---|---|
| Elements of | ||||
| Comparison | Subject Device | Predicate Device I | Predicate Device II | Reference Device |
| 510(k) Number | TBD | K193008 | K190467 | K173678 |
| Device | ||||
| Name | Laser hair grow th helmet | |||
| A-800 | Tricoglam Home Use | iHelmet Hair Grow th | ||
| System | Diode Laser Cap | |||
| Product Code | OAP | OAP | OAP | OAP |
| Regulation | ||||
| Number | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 |
| Regulation | ||||
| Class | 2 | 2 | 2 | 2 |
| LLLT Device | ||||
| Type | LLLT | LLLT | LLLT | LLLT |
| Prescription | OTC | prescription use | OTC | OTC |
| Intended Use | The Laser hair grow th helmet | |||
| (Model: A-800) is intended for | ||||
| the promotion of hair grow th in | ||||
| females with androgenic | ||||
| alopecia w ho have Ludw ig- | ||||
| Savin Classifications I-II, and in | ||||
| males with androgenetic | ||||
| alopecia w ho have Norw ood | ||||
| Hamilton Classifications Ila-V; | ||||
| and both genders having | ||||
| Fitzpatrick Classification of Skin | ||||
| Phototypes I-IV. | Tricoglam Home Use is | |||
| indicated to promote hair grow th | ||||
| in females with androgenetic | ||||
| alopecia who have Ludw ig- | ||||
| Savin Classifications I - II, in | ||||
| males w ith androgenetic | ||||
| alopecia w ho have Norw ood | ||||
| Hamilton Classifications Ila - V | ||||
| and for both, Fitzpatrick | ||||
| Classification of Skin | ||||
| Phototypes of I - IV. | iHelmet Hair Grow th System | |||
| (Model: LTD88Lite, LTD36Air, | ||||
| LTD160Pro) is indicated to | ||||
| promote hair grow th in females | ||||
| w ith androgenetic alopecia w ho | ||||
| have Ludwig-Savin | ||||
| Classifications I - II, in males | ||||
| w ith androgenetic alopecia w ho | ||||
| have Norw ood Hamilton | ||||
| Classifications Ila - V and for | ||||
| both, Fitzpatrick Classification of | ||||
| Skin Phototypes of I - IV. | Diode Laser Cap is indicated to | |||
| promote hair grow th in males | ||||
| w ith androgenic alopecia w ho | ||||
| have Norw ood-Hamilton | ||||
| classifications of Ila-V or | ||||
| females with androgenetic | ||||
| alopecia who have Ludw ig- | ||||
| Savin Classifications of I-II and | ||||
| both w ith Fitzpatrick Skin | ||||
| Phototypes I-IV. | ||||
| Wavelength | 650nm±10nm | 650nm±10nm | 650nm±10nm | 650nm |
| Laser radiation | ||||
| output | 5mW | 5mW | 4~5mW | ≤5mW |
| Fluence | 3.03J / cm² | 1.2 J / cm² | LTD88Lite: 4.1883 J/cm² | |
| LTD36Air: 4.3801 J/cm² | ||||
| LTD160Pro: 4.9642 J/cm² | ||||
| Substantial Equivalence Comparison Table for | ||||
| A-800 | ||||
| Elements of | ||||
| Comparison | Subject Device | Predicate Device I | Predicate Device II | Reference Device |
| Mathematically Max. derived | ||||
| Amount of | ||||
| laser diodes | 180 | 105 | LTD88Lite: 88 | |
| LTD36Air: 36 | ||||
| LTD160Pro: 160 | COSMO-010: 272 | |||
| COSMO-020: 148 | ||||
| COSMO-030: 272 | ||||
| Irradiation over | ||||
| the treatment | ||||
| area | 2.02 mW/cm² | / | LTD88Lite: 2.3533 mW/cm² | |
| LTD36Air: 2.0857 mW/cm² | ||||
| LTD160Pro: 2.3639 mW/cm² | ||||
| Mathematically Max. derived | -- | |||
| Classification | ||||
| according to | ||||
| IEC60825-1 | Class 3R | Class 3R | Class 3R | Class 3R |
| Treatment | ||||
| Time | Each Treatment: 25 min | |||
| Total Treatment: every two days | 16 weeks, 20 minutes in | |||
| continuous every day | Each Treatment: 20-35 min | |||
| Total Treatment: every other | ||||
| day, for 16 weeks | Each treatment: 30min | |||
| 16 weeks, every other day | ||||
| Appearance | ||||
| Design | Helmet cap | Helmet | Helmet | Helmet |
| Safety and | ||||
| Performance | ||||
| Feature | Complied with IEC 60601-1, | |||
| IEC 60601-1-2, IEC 60825-1 | Complied with IEC 60601-1, | |||
| IEC 60601-1-2, IEC 60825-1, | ||||
| IEC 60601-1-11 | Complied with IEC 60601-1, | |||
| IEC 60601-1-2 | Complied with IEC60601-1, | |||
| IEC60601-1-11, IEC60601-1-2 | ||||
| and IEC60825-1 | ||||
| Biocompatibility | All patient contacting materials | |||
| are complied with ISO 10993-5, | ||||
| ISO 10993-10 | All patient contacting materials | |||
| are complied with ISO 10993-5, | ||||
| ISO 10993-10 | All patient contacting materials | |||
| are complied with ISO 10993-5, | ||||
| ISO 10993-10 | All patient contacting materials | |||
| are complied with ISO 10993-5, | ||||
| ISO 10993-10 |
6
Sponsor: Kam Yuen Plastic Products Ltd. Subject Device: Laser hair growth helmet, Model: A-800 File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary
7
5. Summary for clinical test
Clinical performance is not deemed necessary.
6. Performance Test Summary
The Laser hair growth helmet has been evaluated for its safety and performance by lab bench testing as following:
- � Electrical safety and performance test according to IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD) and IEC 60825-1:2014 Safety of laser products - Part 1 : Equipment classification and requirements|Including: Technical Corrigendum 1 (2008) Interpretation Sheet 1 (2007) Interpretation Sheet 2 (2007)]
- � Electromagnetic compatibility test according to IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- � Biocompatibility test according to ISO 10993-5:2009 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity and ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- � Software verification and validation test according to the requirements of the FDA "Guidance for Premarket Submissions and for Software Contained in Medical Devices'
7. Conclusion
The subject device Laser hair growth helmet (A-800) has all features of the predicate devices for intended use. Thus, the subject device is substantially equivalent to the predicate devices.