(130 days)
Not Found
No
The document describes a low-level laser device with a simple access sensor. There is no mention of AI, ML, image processing, or any data processing that would suggest the use of such technologies. The performance studies focus on electrical safety, EMC, and basic software validation, not AI/ML model performance.
Yes
The device is described as treating androgenic alopecia and promoting hair growth, which are therapeutic actions. It is also labeled for "prescription use."
No
The device is described as a "low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth," not to diagnose a condition. Its function is therapeutic rather than diagnostic.
No
The device description explicitly states it includes hardware components such as a host machine, light source (diode lasers), and lifting bracket. It also mentions electrical safety and electromagnetic compatibility testing, which are relevant to hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The Hair Growth System (Model: KN-8000A) is a device that applies low-level laser light directly to the scalp. It is a therapeutic device intended to promote hair growth, not a diagnostic device that analyzes samples.
- Intended Use: The intended use clearly states it's for "prowth in females with androgenic alopecia... and in males with androgenic alopecia..." This is a treatment indication, not a diagnostic one.
- Device Description: The description details a laser device that applies light to the scalp, not a system for analyzing biological samples.
Therefore, based on the provided information, the Hair Growth System is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
OAP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
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
1
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 International
Marketing Group LLC |
|-------------|------------------|-----------------------------------------------|
| Device Name | Capillus devices | Sunetics Clinical Laser
"G" |
4
| | Capillus352;
Capillus302 | |
|----------------------|-----------------------------|-----------------|
| 510(k) Number | K162994 | K132646 |
| Product Code | OAP | OAP |
| Regulation
Number | 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 of
Device Requiring
Biocompatibility | Material of
Component | Body Contact
Category
(ISO 10993-1) | Contact Duration
(ISO 10993-1) |
|------------------------------------------------------|--------------------------|-------------------------------------------------------|-----------------------------------|
| loop bar sucker | silicon rubber | Surface-contacting
device: skin of patient
head | Maximum 30
minutes(