(130 days)
The Hair Growth System (Model: KN-8000A) is a prescription use device intended for the prowth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.
The Hair Growth System Model: KN-8000A is a transportable, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in both Males and Females. It produces a red light, diode lasers operating at a 650-nanometer wavelength (maximum output power of each is 5 mW). The device mainly includes a host machine, light source and lifting bracket. The light source applicator was equipped with the access sensor device, it can power off the light source when the patient's scalp deviates from the work area.
The provided text is a 510(k) summary for the "Hair Growth System (Model: KN-8000A)" and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria for an AI/algorithm-driven device.
Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/algorithm performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details for an AI model.
The "Test Summary" section in the document only mentions:
- Electrical safety test (IEC 60601-1 and IEC 60825-1 standards)
- Electromagnetic compatibility test (IEC 60601-1-2 standard)
- Software verification and validation test (according to FDA guidance for software in medical devices)
These tests are related to the safety and fundamental performance of the device's hardware and software, but not to the clinical effectiveness or performance of an AI component in achieving a specific outcome (like hair growth based on algorithmic assessment). The device itself is described as a "low-level laser device" not explicitly an AI-driven system.
In summary, none of the requested information regarding AI/algorithm acceptance criteria and study details is present in the provided text. The document's purpose is to establish substantial equivalence for a physical device, not to describe the validation of an AI algorithm.
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Xuzhou Kernel Medical Equipment Co., Ltd. % Jet Li Regulation Manager Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, CN
Re: K190685
Trade/Device Name: Hair Growth System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: June 18, 2019 Received: June 28, 2019
July 26, 2019
Dear Jet Li:
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 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
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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.
Neil R. P. Ogden, M.S. Acting Team Assistant Director Light Based Devices Team 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) K190685
Device Name
Hair Growth System Device (Model: KN-8000A)
Indications for Use (Describe)
The Hair Growth System (Model: KN-8000A) is a prescription use device intended for the prowth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.
Type of Use (Select one or both, as applicable)
| X 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: July 26, 2019
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Sponsor
- Company Name: Xuzhou Kernel Medical Equipment Co., Ltd. �
- Address: Kernel Mansion, Economic Development District, Xuzhou City, Jiangsu Province, � China
- Phone: +86 1831 685 8036 �
- Fax: +86 0516-87732208 13776587162 �
- Contact Person (including title): Wang Jing (Management Representative) �
- E-mail: wjkernel@126.com �
Application Correspondent:
Guangzhou KEDA Biological Tech Co., Ltd. Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China Contact Person: Jet Li Tel: +86-18588874857 Email: med-il@foxmail.com
Subject Device Information 2.
- � Trade Name: Hair Growth System (Model: KN-8000A)
- Lamp, non-heating, for promotion of hair growth � Common Name:
- Infrared lamp per 21 CFR 890.5500surgery and in Classification name: � dermatology
- General & Plastic Surgery � Review Panel:
- OAP (Laser, comb, hair) � Product Code:
2
- Requlation Class: �
- 21 CFR 890.5500 � Regulation Number:
3. Predicate Device Information
| Sponsor | Capillus, LLC. | Sunetics InternationalMarketing Group LLC |
|---|---|---|
| Device Name | Capillus devices | Sunetics Clinical Laser"G" |
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| Capillus352;Capillus302 | ||
|---|---|---|
| 510(k) Number | K162994 | K132646 |
| Product Code | OAP | OAP |
| RegulationNumber | 21 CFR 890.5500 | 21 CFR 890.5500 |
| Regulation Class | 2 | 2 |
2. Device Description
The Hair Growth System Model: KN-8000A is a transportable, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in both Males and Females. It produces a red light, diode lasers operating at a 650-nanometer wavelength (maximum output power of each is 5 mW). The device mainly includes a host machine, light source and lifting bracket. The light source applicator was equipped with the access sensor device, it can power off the light source when the patient's scalp deviates from the work area.
5. Intended Use / Indications for Use
The Hair Growth System (Model: KN-8000A) 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 Ila-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.
6. Design
The Hair Growth System (Model: KN-8000A) is designed to be free to stretch and be able to take care of every part of the scalp in consideration of the characteristics of the human head. The device laser light source is arranged in matrix structure with dot scope to balance the light energy. Light source shall achieve the fixation of light source and connections with electrical through the military-class quick connector, which makes it more convenient and faster to replace the light source. Free lift shall be designed of cantilever, so that the light source can stay at any angle. 8 "rotatable touch screen design, easy to operate, which does not need the professional training. According to the difference of the treatment parts, each treatment hood array can be controlled individually . According to treatment needs, the continuous irradiation or pulse irradiation mode can be selected. There is the function of auxiliay display in the light source, to facilitate doctors to timely grasp the treatment time information. There is the access sensor in the treatment applicator of the hood array. When the patient's scalp deviate from the work area, the light source can be stopped in time to ensure patient safety. Working distance positioning equipment, to facilitate users to quickly adjust to the appropriate working distance. Double switch protections of key switch and power-on password, to prevent the use of unauthorized personnel.
7. Materials
There is one kind of patient- directly contacting component in the subject device as the following list.
| Component ofDevice RequiringBiocompatibility | Material ofComponent | Body ContactCategory(ISO 10993-1) | Contact Duration(ISO 10993-1) |
|---|---|---|---|
| loop bar sucker | silicon rubber | Surface-contactingdevice: skin of patienthead | Maximum 30minutes(<24hours) |
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|--|--|--|--|
We conduct biocompatibility test on the material of loop bar sucker. So the parts' biocompatibility is safe.
8. Physical characteristics
| Basic Unit Characteristics | |
|---|---|
| Compliance* with 21 CFR 898 | No |
| Main Unit Weight | 3.0-4.0 kg |
| Housing Materials of main unit | ABS |
| Environment for operation | Temperature: 5 ~ 40 °C |
| Relative humidity: ≤85% | |
| Atmospheric pressure: 700hPa ~ 1060hPa | |
| Storage and Transport Conditions | Temperature: -5 ~ 40 °C |
| Relative humidity: 10-95% | |
| Atmospheric pressure: 700hPa ~ 1060hPa | |
| Compliance with VoluntaryStandards | Yes, Comply with IEC 60601-1, IEC 60601-1-2,IEC 60825-1 |
| Patient leakage current | Comply with IEC 60601-1 |
| Power Source | AC 100-240V, 50 / 60Hz ± 2% |
| Software/Firmware/MicroprocessorControl? | Yes |
| Specification | |
| Input power | 120VA |
| The specification and rating value offuse protector | T1.5AL / 250V Φ5 * 20 |
| Structure style of stand | Cart type |
| Radiation area | 900 cm²±10% |
| Irradiation distance | 4cm±1cm |
| Laser Category | 3R laser products |
| Laser output wavelength | 650nm±10nm |
| Maximum output laser radiation | <5mW |
| Technology | Laser |
10. Test Summary
The Hair Growth System has been evaluated for its safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1 and IEC 60825-1 standards �
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Software verification and validation test according to the requirements of the FDA "Guidance for PreMarket Submissions and for Software Contained in Medical Devices"
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11. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, and intended use of Hair Growth System, model: KN-8000A 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.
| Elements ofComparison | Subject Device | Predicate Device I | Predicate Device II |
|---|---|---|---|
| 510(k) Number | Candidate | K162994 | K132646 |
| Device Name | Hair Growth System | Capillus DevicesCapillus352;Capillus 302 | Sunetics Clinical Laser"G" |
| LLLT Device Type | LLLT | LLLT | LLLT |
| Prescription | Prescription Use | Prescription Use | Prescription Use |
| Intended Use | intended for thepromotion of hairgrowth in females withandrogenic alopeciawho have Ludwig-Savin Classifications I-II, and in males withandrogenetic alopeciawho have NorwoodHamiltonClassifications IIa-V;and both gendershaving FitzpatrickClassification of SkinPhototypes I-IV. | intended to treatAndrogeneticAlopecia andpromote hair growthin males who haveNorwood-HamiltonClassifications of IIato V patterns ofhair loss and to treatAndrogeneticAlopecia and promotehair growth in femaleswho have Ludwig(Savin) Scale I-1 to I-4, II-1, II-2, or frontal;both with FitzpatrickSkin Types I to IV. | The Sunetics ClinicalLaser (model 'G" &model "W2326") isindicated totreat AndrogeneticAlopecia (Hair Loss)and to promote hairgrowth in Maleswho have NorwoodHamilton Classificationsof IIa to V andFitzpatrick SkinTypes I to IV and alsoin Females who haveLudwig (Savin) 1-4.11I-1, 11-2, orfrontal patterns of hairloss & Fitzpatrick SkinTypes I to IV. |
| Laser Diode Class | 3R | 3R | 3R |
| Design | Hood array | Helmet/Cap | Hood array |
| Laser Diode Power | $4.5mW \pm 10%$ | 5mW max | 5mW max |
| Wavelength | 650nm | 650nm | 650nm |
| Irradiance (powerper area) | 2.332mW/cm2 | Capillus352: 2.745mW/cm2Capillus302: 2.256mW/cm2 | |
| Classification | OAP | OAP | OAP |
| Classification Name | Infrared Lamp | Infrared Lamp | Infrared Lamp |
| Common Usage Name | Lamp, Non-Heating | Lamp, Non-Heating | Lamp, Non-Heating |
| Review Panel | General & PlasticSurgery Committee | General & PlasticSurgery Committee | General & PlasticSurgery Committee |
| Elements ofComparison | Subject Device | Predicate Device I | Predicate Device II |
| Fitzpatrick SkinPhototypes | I- IV | I- IV | I- IV |
| Ludwig-Savin Scale(women) | Ludwig-Savin I-II(females) | Ludwig-Savin I-II(females) | Ludwig-Savin I-II(females) |
| Norwood-Hamilton(men) | Norwood Hamilton IIA-V (males) | Norwood Hamilton IIA-V (males) | Norwood Hamilton IIA-V (males) |
| Treatment Frequency | Treatment- 17weeks, every other day (indefinite) | Treatment- 17weeks, every other day (indefinite) | every other day (indefinite) |
| Device Class | II | II | II |
| Biocompatibility | ISO 10993-5;ISO10993-10 | ISO 10993-5;ISO10993-10 | ISO 10993-5;ISO10993-10 |
| Safety and EMCstandard | IEC 60601-1;IEC60601-1-2 | IEC 60601-1;IEC60601-1-2 | IEC 60601-1;IEC60601-1-2 |
| Laser performancestandard | IEC60825-1 | IEC60825-1 | IEC60825-1 |
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§ 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.