(60 days)
Neuhat Hair Growth System is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV.
ibeauty.com Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV.
The System includes NEU180 and NEU300 two models.
NEU180 consists of 50 laser diodes with wavelength at 655mm, power ≤5mW, and 130 red light diodes with wavelength at 650 nm, power ≤5mW.
NEU300 consists of 100 laser diodes with wavelength at 655nm, power ≤5mW, and 200 red light diodes with wavelength at 650 nm, power ≤5mW.
The System is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an adapter.
The provided text is an FDA 510(k) summary for a medical device called "Neuhat Hair Growth System" (or "ibeauty.com Laser Cap"). This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria for a novel AI/device performance.
Therefore, the information required to answer your specific questions about acceptance criteria for an AI/device, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance is not present in this document.
This 510(k) summary for the Neuhat Hair Growth System primarily discusses:
- Device Description: It describes the two models (NEU180 and NEU300) with their laser and LED diode counts, wavelengths, and power.
- Indications for Use: It specifies the target population (males with Norwood-Hamilton classifications IIa-V and females with Ludwig-Savin classifications I-II, and Fitzpatrick Skin Phototypes I-IV) for promoting hair growth.
- Comparison to Predicate Devices: It provides a comprehensive comparison of technological characteristics (intended use, users, location, type of light, wavelength, number of diodes, energy, treatment time, applicable people/skin types, helmet/cap design, biocompatibility features) to two predicate devices (K210169 and K200464) to show substantial equivalence.
- Performance Data (Non-Clinical): It lists the biocompatibility testing (ISO 10993-5 and ISO 10993-10) and electrical and EMC safety testing (various IEC 60601 and IEC 62471 standards) that were performed and passed.
In summary, this document does not contain the type of data or study design (e.g., clinical trial data, AI performance metrics, expert adjudication details) that would allow for a complete answer to your request. The purpose of this 510(k) is to demonstrate that the device is as safe and effective as a legally marketed device, not to present a new clinical efficacy study with specific performance targets.
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June 23, 2023
Nature Incredible Inc John Lee General Manager 3422 Old Capitol Trail #569 Wilmington, Delaware 19808
Re: K231153
Trade/Device Name: Neuhat Hair Growth System; ibeauty.com Laser Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: April 24, 2023 Received: April 24, 2023
Dear John 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.
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
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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 (OS) 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,
Jianting Wang -S
Jianting Wang 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
Enclosure
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Indications for Use
510(k) Number (if known) K231153
Device Name Neuhat Hair Growth System ibeauty.com Laser Cap
Indications for Use (Describe)
Neuhat Hair Growth System is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV.
ibeauty.com Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and 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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510(k) Summary K231153
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: 2023-06-22
1. 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
2. Device
Type of 510(k): Traditional Common Name: Lamp, non-heating, for promotion of hair growth Trade Name: Neuhat Hair Growth System (or ibeauty.com Laser Cap) Model: NEU180, NEU300 Regulation Name: Review Panel: General & Plastic Surgery Regulatory Class: II Product Code: OAP Regulation Number: 21 CFR 890.5500
3. Predicate Device
| Applicant | Primary PredicateDevice | Reference device |
|---|---|---|
| 510(k) Number | K210169 | K200464 |
| Trade name | Hair Growth Device | LG Pra.L Derma LDScalp Care |
| Model | LS-D601 | / |
| Regulation name | Infrared Lamp | Infrared Lamp |
| Review Panel | General & PlasticSurgery | General & PlasticSurgery |
| Regulation Class | Class II | Class II |
| Regulation number | 21 CFR 890.5500 | 21 CFR 890.5500 |
| Product code | OAP | OAP |
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Device Description 4.
The System includes NEU180 and NEU300 two models.
NEU180 consists of 50 laser diodes with wavelength at 655mm, power ≤5mW, and 130 red light diodes with wavelength at 650 nm, power ≤5mW.
NEU300 consists of 100 laser diodes with wavelength at 655nm, power ≤5mW, and 200 red light diodes with wavelength at 650 nm, power ≤5mW.
The System is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an adapter.
Indications for Use 5.
Neuhat Hair Growth System is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV.
ibeauty.com Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV.
6. Comparison of Technological Characteristics With the Predicate Device
Neuhat Hair Growth System (or ibeauty.com Laser Cap) raises no safety or efficacy concerns as compared to the predicate devices.
| ComparisonElements | Subject Device | Primary PredicateDevice | Reference device I | Remark |
|---|---|---|---|---|
| K Number | Pending | K210169 | K200464 | / |
| Trade name | Neuhat Hair GrowthSystem (oribeauty.com LaserCap) | Hair Growth Device | LG Pra. L Derma LDScalp Care | / |
| Model | NEU300, NEU180 | LS-D601 | / | / |
| Classificationname | Infrared Lamp | Infrared Lamp | Infrared Lamp | Same |
| Product code | OAP | OAP | OAP | Same |
| ComparisonElements | Subject Device | Primary PredicateDevice | Reference device I | Remark |
| Intendeduse/Indicationsfor Use | Neuhat Hair GrowthSystem is indicatedto promote hairgrowth in males withandrogenic alopeciawho have Norwood-Hamiltonclassifications of IIa-V and females withandrogenic alopeciawho have Ludwig-Savin Classificationsof I-II and FitzpatrickClassification of SkinPhototypes I-IV.ibeauty.com LaserCap is indicated topromote hair growthin males withandrogenic alopeciawho have Norwood-Hamiltonclassifications of IIa-V and females withandrogenic alopeciawho have Ludwig-Savin Classificationsof I-II and FitzpatrickClassification of SkinPhototypes I-IV. | The Hair GrowthDevice is indicated topromote hair growthin males withandrogenetic alopeciawho have Hamilton-NorwoodClassifications of Ila-V and females withandrogenetic alopeciawho have Ludwig-Savin Classificationsof I-II and FitzpatrickClassification of SkinPhototypes I to IV. | The LG Pra.L Derma LDScalp Care is indicatedto promote hair growthin males withandrogenetic alopeciawho have Hamilton-Norwood Classificationsof IIa-V and femaleswith androgeneticalopecia who haveLudwig-SavinClassifications of I-IIand FitzpatrickClassification of SkinPhototypes I to IV. | Same |
| Intended user | Both sex | Both sex | Both sex | Same |
| Location for use | OTC application | OTC application | OTC application | Same |
| Type of Light | Low-level laserdiodes and lightemitting diodes | Low-level laser diodesand light emittingdiodes | Low-level laser diodesand light emitting diodes | Same |
| ComparisonElements | Subject Device | Primary PredicateDevice | Reference device I | Remark |
| Wavelength | Laser: 655nmRed light LED:650nm | Laser: 650-660nmRed light LED: 640-660nm | Laser: 650-667nmRed light LED: 645-665nm | Subjectdevice iswithin thebandwidthof predicateandreferencedevices |
| Amount of laserdiodes | NEU300Laser diodes: 100LED diodes: 200 | Laser diodes: 26LED diodes: 30 | Subjectdevice iswithin thebandwidthbetweenpredicateandreferencedevices | |
| NEU180Laser diodes: 50LED diodes: 130 | Laser diodes: 250LED diodes: 250 | Subjectdevice iswithin thebandwidthbetweenpredicateandreferencedevices | ||
| Energy of perlaser diode | 5mW | 5mW | 5mW | Same |
| Treatment time | Each treatment: 25minsTotal Treatment:16 weeks, everyother day (indefinite) | Each treatment: 25minsTotal Treatment:16 weeks, every otherday (indefinite) | Each treatment:18minutes or 27 minutesTotal Treatment:16 weeks, every otherday (indefinite) | Same |
| Applicablepeople | Norwood-HamiltonIIa | Norwood-HamiltonIIa | Norwood-HamiltonIIa | Same |
| Applicable skin | Fitzpatrick SkinPhototypes I-IV | Fitzpatrick SkinPhototypes I-IV | Fitzpatrick SkinPhototypes I-IV | Same |
| Helmet/Capdesign | Yes | Yes | Yes | Same |
| ComparisonElements | Subject Device | Primary PredicateDevice | Reference device I | Remark |
| Biocompatibilityfeature | All body-contactingmaterials arecomplied withISO10993-5 andISO 10993-10 | All body-contactingmaterials arecomplied withISO10993-5 and ISO10993-10 | All body-contactingmaterials are compliedwith ISO10993-5 andISO 10993-10 | Same |
A technical comparison to the predicate is provided below:
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7. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocomnatibility Testing 1)
The biocompatibility evaluation for the body-contacting components of Neuhat Hair Growth System (or ibeauty.com 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 September 2020", as recognized by FDA. The battery of testing was performed to, and passed, including:
- A ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
- A 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:
- A IEC 60601-1 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
- A IEC 60601-4-2 Medical electrical equipment - Part 4-2: Guidance and interpretation -Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
- 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 60601-1-2 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: electromagnetic compatibility - Requirements and tests
- A IEC 60601-2-57 Medical Electrical Equipment-Part 2-57: Particular Requirements For The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesthetic Use
- A IEC 62471 Photobiological Safety of Lamps and Lamp Systems
- IEC 60825-1 Safety of laser products-Part 1: Equipment classification, and requirements A
3) Summarv
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Based on the above performance as documented in this application, Neuhat Hair Growth System (or ibeauty.com Laser Cap) was found to have a safety and effectiveness profile that is same as the predicate device.
8. 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, Neuhat Hair Growth System (or ibeauty.com Laser Cap) is to be concluded same to its predicate devices and reference 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.