(233 days)
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.
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.
The medical device is the Laser hair growth helmet (Model: A-800), intended for the promotion of hair growth in females with Ludwig-Savin Classifications I-II and males with Norwood Hamilton Classifications IIa-V, both with Fitzpatrick Classification of Skin Phototypes I-IV.
1. A table of acceptance criteria and the reported device performance:
The provided document does not contain explicit "acceptance criteria" for clinical performance. Instead, it states that "Clinical performance is not deemed necessary" and focuses on demonstrating substantial equivalence to predicate devices through technical specifications and safety/performance bench testing. The device's performance is therefore reported in terms of its technical characteristics matching or being comparable to predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (Laser hair growth helmet Model: A-800) |
|---|---|
| Intended Use | The Laser hair growth helmet (Model: A-800) is intended for the promotion of hair growth in females with Ludwig-Savin Classifications I-II, and in males with Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV. (Matches predicates) |
| LLLT Device Type | LLLT |
| Prescription Type | OTC (Matches Predicate II & Reference Device; Predicate I is prescription use) |
| Wavelength | 650nm ± 10nm (Matches all predicates) |
| Laser radiation output | 5mW (Matches Predicate I & Reference Device; Predicate II is 4-5mW) |
| Fluence | 3.03 J/cm² (Comparable to predicates, which range from 1.2 J/cm² to 4.9642 J/cm²) |
| Amount of laser diodes | 180 (Falls within the range of predicates: 36-272) |
| Irradiation over the treatment area | 2.02 mW/cm² (Comparable to Predicate II's range: 2.0857-2.3639 mW/cm²) |
| Classification according to IEC60825-1 | Class 3R (Matches all predicates) |
| Treatment Time (Each Treatment) | 25 min (Comparable to predicates: 20-35 min/30 min) |
| Treatment Time (Total Treatment) | Every two days (Comparable to predicates: every day/every other day) |
| Appearance Design | Helmet cap (Matches predicates: Helmet) |
| Safety and Performance Feature Compliance | Complied with IEC 60601-1, IEC 60601-1-2, IEC 60825-1 |
| Biocompatibility Compliance | All patient contacting materials complied with ISO 10993-5, ISO 10993-10 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No clinical test set was used for this submission. The submission explicitly states: "Clinical performance is not deemed necessary." The data provenance for the performance testing is from laboratory bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set was used and clinical performance was not deemed necessary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set was used.
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 hair growth helmet, not an AI-assisted diagnostic or interpretative tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical device, not an algorithm, and the submission did not include standalone clinical performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
No clinical ground truth was established or used, as no clinical trials were conducted for this submission. The "ground truth" for demonstrating device compliance was based on adherence to recognized international standards for electrical safety, electromagnetic compatibility, laser safety, and biocompatibility, as well as verification and validation for integral software.
8. The sample size for the training set:
Not applicable, as no machine learning algorithm or AI component requiring a training set was part of this device submission.
9. How the ground truth for the training set was established:
Not applicable, as no machine learning algorithm or AI component requiring a training set was part of this device submission.
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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.
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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 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
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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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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 �
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- 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 |
| DeviceName | Tricoglam Home Use | iHelmet Hair Grow thSystem | Diode Laser Cap |
| Product Code | OAP | OAP | OAP |
| RegulationNumber | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 |
| RegulationClass | 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.
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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 forA-800 | ||||
|---|---|---|---|---|
| Elements ofComparison | Subject Device | Predicate Device I | Predicate Device II | Reference Device |
| 510(k) Number | TBD | K193008 | K190467 | K173678 |
| DeviceName | Laser hair grow th helmetA-800 | Tricoglam Home Use | iHelmet Hair Grow thSystem | Diode Laser Cap |
| Product Code | OAP | OAP | OAP | OAP |
| RegulationNumber | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 |
| RegulationClass | 2 | 2 | 2 | 2 |
| LLLT DeviceType | LLLT | LLLT | LLLT | LLLT |
| Prescription | OTC | prescription use | OTC | OTC |
| Intended Use | The Laser hair grow th helmet(Model: A-800) is intended forthe promotion of hair grow th infemales with androgenicalopecia w ho have Ludw ig-Savin Classifications I-II, and inmales with androgeneticalopecia w ho have Norw oodHamilton Classifications Ila-V;and both genders havingFitzpatrick Classification of SkinPhototypes I-IV. | Tricoglam Home Use isindicated to promote hair grow thin females with androgeneticalopecia who have Ludw ig-Savin Classifications I - II, inmales w ith androgeneticalopecia w ho have Norw oodHamilton Classifications Ila - Vand for both, FitzpatrickClassification of SkinPhototypes of I - IV. | iHelmet Hair Grow th System(Model: LTD88Lite, LTD36Air,LTD160Pro) is indicated topromote hair grow th in femalesw ith androgenetic alopecia w hohave Ludwig-SavinClassifications I - II, in malesw ith androgenetic alopecia w hohave Norw ood HamiltonClassifications Ila - V and forboth, Fitzpatrick Classification ofSkin Phototypes of I - IV. | Diode Laser Cap is indicated topromote hair grow th in malesw ith androgenic alopecia w hohave Norw ood-Hamiltonclassifications of Ila-V orfemales with androgeneticalopecia who have Ludw ig-Savin Classifications of I-II andboth w ith Fitzpatrick SkinPhototypes I-IV. |
| Wavelength | 650nm±10nm | 650nm±10nm | 650nm±10nm | 650nm |
| Laser radiationoutput | 5mW | 5mW | 4~5mW | ≤5mW |
| Fluence | 3.03J / cm² | 1.2 J / cm² | LTD88Lite: 4.1883 J/cm²LTD36Air: 4.3801 J/cm²LTD160Pro: 4.9642 J/cm² | |
| Substantial Equivalence Comparison Table forA-800 | ||||
| Elements ofComparison | Subject Device | Predicate Device I | Predicate Device II | Reference Device |
| Mathematically Max. derived | ||||
| Amount oflaser diodes | 180 | 105 | LTD88Lite: 88LTD36Air: 36LTD160Pro: 160 | COSMO-010: 272COSMO-020: 148COSMO-030: 272 |
| Irradiation overthe treatmentarea | 2.02 mW/cm² | / | LTD88Lite: 2.3533 mW/cm²LTD36Air: 2.0857 mW/cm²LTD160Pro: 2.3639 mW/cm²Mathematically Max. derived | -- |
| Classificationaccording toIEC60825-1 | Class 3R | Class 3R | Class 3R | Class 3R |
| TreatmentTime | Each Treatment: 25 minTotal Treatment: every two days | 16 weeks, 20 minutes incontinuous every day | Each Treatment: 20-35 minTotal Treatment: every otherday, for 16 weeks | Each treatment: 30min16 weeks, every other day |
| AppearanceDesign | Helmet cap | Helmet | Helmet | Helmet |
| Safety andPerformanceFeature | 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, IEC60601-1-2and IEC60825-1 |
| Biocompatibility | All patient contacting materialsare complied with ISO 10993-5,ISO 10993-10 | All patient contacting materialsare complied with ISO 10993-5,ISO 10993-10 | All patient contacting materialsare complied with ISO 10993-5,ISO 10993-10 | All patient contacting materialsare complied with ISO 10993-5,ISO 10993-10 |
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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
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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.
§ 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.