(57 days)
No
The description focuses on the hardware (lasers, LEDs, battery) and basic automated functions (pausing therapy based on head position, audible prompts). There is no mention of AI, ML, or any data processing that would suggest intelligent algorithms are used for diagnosis, treatment planning, or personalized therapy.
Yes.
The device is intended for the promotion of hair growth in individuals with androgenic alopecia, which is a medical condition, making it a therapeutic device.
No
The device is intended for the promotion of hair growth, not for diagnosing medical conditions.
No
The device description explicitly states it is a "low-level laser device, which consists of red visible light diode lasers and/or LEDs" and is a "hands-free, portable, noninvasive" system, indicating it is a physical hardware device. While it mentions software verification and validation, this is for software contained within the hardware device, not a standalone software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Hair Growth System described is a non-invasive, low-level laser device that applies light directly to the scalp to promote hair growth. It does not involve the collection or analysis of any biological specimens.
- Intended Use: The intended use is for the promotion of hair growth in individuals with specific types of alopecia. This is a therapeutic application, not a diagnostic one.
The device is a medical device, but it falls under a different category than IVDs. It's a therapeutic device that uses light energy.
N/A
Intended Use / Indications for Use
The Hair Growth System (Model: KN-8000B/KN-8000C/KN-8000E) 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.
Product codes
OAP
Device Description
The Hair Growth System (Model: KN-8000B/KN-8000D/KN-8000E) is hands-free, portable, noninvasive, low-level laser device, which consists of red visible light diode lasers and/or LEDs, 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 pause therapy if the user's head is moved outside of the zone of radiation and will resume therapy when the correct head position is reestablished.
The device could be powered by internal rechargeable li-on battery (Rated 7.2Vd.c. 2100mAh), and it can also be supplied by specified external adapter with rated Input 100-240Vac. 50/60Hz and rated Output 9Vdc 3A.
For KN-8000D and KN-8000E, the device emits an audible voice prompt when the treatment is going to start/pause/end, and the device is going to shut down.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hair/Scalp (implied for hair growth)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
The Hair Growth System has been evaluated for its safety and performance by lab bench testing as following:
- Electrical safety and performance test according to IEC 60601-1, IEC 60825-1, IEC 62471 and IEC 60601-2-57 standard
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standard
- Usability test according to IEC 62366
- 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)
K173846, K163170, K151662, K183417
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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June 3, 2020
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, Guangdong China
Re: K200929
Trade/Device Name: Hair Growth System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: March 15, 2020 Received: April 7, 2020
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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,
Colin Kejing Chen, Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200929
Device Name
Hair Growth System (Model: KN-8000B/KN-8000C/KN-8000D/KN-8000E)
Indications for Use (Describe)
The Hair Growth System (Model: KN-8000B/KN-8000C/KN-8000E) 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Date of the summary prepared: May 30, 2020
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. This is a traditional 510(K) submission with no previous application.
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: wikernel@126.com �
Application Correspondent:
- Company Name: 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-jl@foxmail.com �
Subject Device Information 2.
- � Trade Name: Hair Growth System
- Model: KN-8000B/KN-8000C/KN-8000D/KN-8000E �
| Data
| Model | LD Quantity | LED Quantity |
|---|---|---|
| KN-8000B | 204 | -- |
| KN-8000C | 80 | 30 |
| KN-8000D | 21 | 30 |
| KN-8000E | 81 | -- |
- Common Name: Lamp, non-heating, for promotion of hair growth �
- Classification name: Infrared lamp �
- � Review Panel: General & Plastic Surgery
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- Product Code: OAP (Laser, comb, hair) �
- � Requlation Class: 2
- Regulation Number: 21 CFR 890.5500 �
3. Predicate Device Information
- � Predicate Devices for KN-8000B and KN-8000E
| Predicate I | Predicate II | |
|---|---|---|
| Sponsor | DermaScalp LLC | Capillus LLC |
| Device Name | DermaScalp Laser Cap | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 |
| 510(k) Number | K173846 | K163170 |
| Product Code | OAP | OAP |
| Regulation Number | 21 CFR 890.5500 | 21 CFR 890.5500 |
| Regulation Class | 2 | 2 |
Predicate Devices for KN-8000C and KN-8000D �
| Predicate I | Predicate II | |
|---|---|---|
| Sponsor | Freedom Laser Therapy, Inc. | Freedom Laser Therapy, Inc. |
| Device Name | iRestore Hair Grow th System | iRestore Professional 282 |
| 510(k) Number | K151662 | K183417 |
| 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-8000B/KN-8000D/KN-8000E) is hands-free, portable, noninvasive, low-level laser device, which consists of red visible light diode lasers and/or LEDs, 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 pause therapy if the user's head is moved outside of the zone of radiation and will resume therapy when the correct head position is reestablished.
The device could be powered by internal rechargeable li-on battery (Rated 7.2Vd.c. 2100mAh), and it can also be supplied by specified external adapter with rated Input 100-240Vac. 50/60Hz and rated Output 9Vdc 3A.
For KN-8000D and KN-8000E, the device emits an audible voice prompt when the treatment is going to start/pause/end, and the device is going to shut down.
5
3. Intended Use / Indications for Use
The Hair Growth System (Model: KN-8000B/KN-8000C/KN-8000E) 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.
4. Test Summary
The Hair Growth System has been evaluated for its safety and performance by lab bench testing as following:
- � Electrical safety and performance test according to IEC 60601-1, IEC 60825-1, IEC 62471 and IEC 60601-2-57 standard
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standard
- � Usability test according to IEC 62366
- � Software verification and validation test according to the requirements of the FDA "Guidance for Premarket Submissions and for Software Contained in Medical Devices"
5. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, and intended use of Hair Growth System, model: KN-8000B/KN-8000D/KN-8000E 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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| Substantial Equivalence Comparison Table for
| KN-8000B/KN-8000E | |||||
|---|---|---|---|---|---|
| Elements of Comparison | Subject Device | Predicate Device I | Predicate Device II | Verdict | |
| 510(k) Number | TBD | K173846 | K163170 | -- | |
| Device Name | Hair Grow th System | ||||
| KN-8000B/ KN-8000E | DermaScalp Laser Cap | Capillus 82, Capillus 202, Capillus | |||
| 272 Pro, 272 Office Pro, Capillus | |||||
| 302, Capillus 312, and Capillus 352 | -- | ||||
| Product Code | OAP | OAP | OAP | SE | |
| Regulation Number | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 | SE | |
| Regulation Class | 2 | 2 | 2 | SE | |
| LLLT Device Type | LLLT | LLLT | LLLT | SE | |
| Prescription | OTC | OTC | OTC | SE | |
| Intended Use | The Hair Grow th System (Model: KN- | ||||
| 8000B/KN-8000C/KN-8000D/KN-8000E) is | |||||
| intended for the promotion of hair grow th in | |||||
| females with androgenic alopecia w ho | |||||
| have Ludwig-Savin Classifications I-II, and | |||||
| in males with androgenetic alopecia w ho | |||||
| have Norwood Hamilton Classifications Ila- | |||||
| V; and both genders having Fitzpatrick | |||||
| Classification of Skin Phototypes I-IV. | The family of DermaScalp Laser Cap | ||||
| devices are indicated to treat | |||||
| Androgenetic Alpopecia and promote | |||||
| hair grow th in Males w ho have | |||||
| Norw ood Hamilton Classifications of | |||||
| Ila to V patterns of hair loss and to | |||||
| treat Androgenetic Alopecia and | |||||
| promote hair grow th in Females w ho | |||||
| have Ludwig (Savin) Scale I-1 to I-4, | |||||
| Il-1, Il-2, or frontal; both with | |||||
| Fitzpatrick Skin Types I to IV. | The Capillus laser domes 82, 202, 272 | ||||
| Pro, 272 OfficePro, 302, 312, and 352, | |||||
| are intended to treat Androgenetic | |||||
| Alopecia and promote hair grow th in | |||||
| males w ho have Norw ood -Hamilton | |||||
| Classifications of Ila to V patterns of | |||||
| hair loss and to treat Androgenetic | |||||
| Alopecia and promote hair grow th in | |||||
| females who have Ludwig (Savin) Scale | |||||
| I-1 to I-4, II-1, II-2, or frontal; both with | |||||
| Fitzpatrick Skin Types I to IV. | SE | ||||
| Minor | |||||
| difference | |||||
| Waveform | Visible red laser | Visible red laser | Visible red laser | SE | |
| Wavelength | 655nm ±5nm | 650nm | 650nm | SE | |
| Note 1 | |||||
| Amounts of laser diode | KN-8000B: 204 | ||||
| KN-8000E: 81 | 50, 80, 120, 148, 180, 202, 224, 272 | 82, 202, 272, 302, 312, 352 | SE | ||
| Note 2 | |||||
| Laser radiation output |