(200 days)
No
The device description and performance studies do not mention any AI or ML components or capabilities. The device is a simple laser comb with basic electrical and laser safety features.
Yes
The device is intended to promote hair growth in individuals with androgenic alopecia by stimulating hair follicles, which is a therapeutic effect.
No
The device is described as an over-the-counter (OTC) home-use low-level laser therapy (LLLT) device intended to promote hair growth. Its function is to provide laser energy to stimulate hair follicles, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly details physical components such as a comb-shaped mainframe, PCB circuit board, power button, indicator light, red laser light, teeth, USB charging port, and an internal rechargeable lithium battery. It also describes the device emitting laser light and using physical mechanisms (teeth) to part hair. This indicates a hardware-based device with potential software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Intelligence Laser Comb is a device that applies laser light directly to the scalp to stimulate hair growth. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is to promote hair growth, not to diagnose or monitor a medical condition through the analysis of in vitro samples.
- Device Description: The description focuses on the physical components and how the laser light interacts with the scalp. There is no mention of collecting or analyzing biological specimens.
Therefore, the Intelligence Laser Comb falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intelligence Laser Comb (Model: YTLC001-W ) is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.
Product codes
OAP
Device Description
The Intelligence Laser Comb (Model: YTLC001-W) is a home-use comb-shaped low level laser therapy (LLLT) device that emits laser light with the intention to promote hair growth in men and women. The device provides distributed laser to the scalp at 655+/-10nm while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The Laser Comb is an over-the-counter (OTC) device intended for home-use.
The Laser Comb works by providing laser energy to stimulate hair follicles. For optimal results, the laser must not be blocked by the hair and must have an unobstructed path to the scalp. The Laser Comb has teeth that part the hair and allow the maximum amount of laser energy to reach the scalp.
The Laser Hair Growth Comb design with plastic Mainframe, it is composed of PCB circuit board, Power Button, Indicator Light, Red Laser Light, Teeth, USB charging port. And the device is equipped with one internal rechargeable lithium battery (3.7 V d.c. 500mA) that can be charged directly by external adapter. The device uses beep and vibrate to alert the user to the next step during treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home-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 Intelligence LaserComb (Model: YTLC001-W) was evaluated for conformance to recognized international standards. The following is a list of these evaluations and tests that were found to be in conformance:
. Electrical safety test
IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC60601-1-11:2015 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
IEC 60825:2014 Safety of laser products - Part 1: Equipment classification and requirements
. Electromaqnetic compatibility test
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
. Biocompatibility test
ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
. Software verification and validation test
FDA "Guidance for Premarket Submissions and for Software Contained in Medical Devices"
- Software Life Cycle Processes
IEC 62304:2006+AMD1:2015 Medical Device Software
Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the Intelligence LaserComb (Model: YTLC001-W) was conducted in accordance with the ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, as recognized by FDA.
The battery of testing was performed to, and passed, including:
ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity,
ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Electrical and EMC Safety
Electrical safety and EMC safety testing was performed to, and passed, the following standards:
IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC60601-1-11:2015 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
IEC 60825:2014 Safety of laser products - Part 1: Equipment classification and requirements
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
Summary for clinical test
Clinical performance is not deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
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June 24, 2022
Yibin Yingtong Intelligent Technology Co.,Ltd. % Iris Fung Official Correspondent SGS-CSTC Standards Technical Services Co., Ltd. 198 Kezhu Road, Scientech Park Guangzhou Economic & Technology Development District Guangzhou, Guangdong 510000 China
Re: K213789
Trade/Device Name: Intelligence LaserComb Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: May 10, 2022 Received: May 11, 2022
Dear Iris Fung:
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.
1
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 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 (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.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213789
Device Name Intelligence Laser Comb (Model: YTLC001-W )
Indications for Use (Describe)
The Intelligence Laser Comb (Model: YTLC001-W ) is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Presentation Use of CFR 221 Subpart C | One-Time Contact Use of CFR 221 Subpart C |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Date of the summary prepared: June 17, 2022
510(k) Summary
510K number: K213789
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: YIBIN YINGTONG INTELLIGENT TECHNOLOGY CO.,LTD.
- Address: 3F, Building 1, Area A, Intelligent terminal industrial park, Yibin economic development � zone, Sichuan province, China
- � Phone: +86 0831-2020866
- Contact Person (including title): Pengcheng Pan (Manager) �
- E-mail: tony@interthings.cn �
Application Correspondent
- � SGS-CSTC Standards Technical Services Co., Ltd.
- Address: 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology � Development District, Guangzhou, Guangdong, CHINA
- Contact Person: Ms. Iris Fung �
- � Tel: +86-20-32136908
- � Email: Iris.Fung@sgs.com; jianda-lee@foxmail.com
2. Subject Device Information
- ◆ Type of 510(k) submission: Traditional
- ♦ Common Name: Lamp, non-heating, for promotion of hair growth
- ♦ Trade Name: Intelligence Laser Comb
- � Model: YTLC001-W
- ◆ 510(K) Number: K213789
- ♦ Classification Name: Laser, Comb, Hair
- ♦ Review Panel: General & Plastic Surgery
- ◆ Product Code: OAP
- ◆ Requlation Number: 890.5500
- ◆ Regulation Class: II
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3. Predicate Device Information
| Predicate Device | |
|---|---|
| Sponsor | OMM IMPORTS INC DBA ZERO |
| GRAVITY | |
| Device Name | Laser Hair Therapy |
| Model | Recreo 200 |
| 510(k) Number | K183329 |
| Product Code | OAP |
| Regulation Number | 890.5500 |
| Regulation Class | II |
2. Device Description
The Intelligence Laser Comb (Model: YTLC001-W) is a home-use comb-shaped low level laser therapy (LLLT) device that emits laser light with the intention to promote hair growth in men and women. The device provides distributed laser to the scalp at 655+/-10nm while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The Laser Comb is an over-the-counter (OTC) device intended for home-use.
The Laser Comb works by providing laser energy to stimulate hair follicles. For optimal results, the laser must not be blocked by the hair and must have an unobstructed path to the scalp. The Laser Comb has teeth that part the hair and allow the maximum amount of laser energy to reach the scalp.
The Laser Hair Growth Comb design with plastic Mainframe, it is composed of PCB circuit board, Power Button, Indicator Light, Red Laser Light, Teeth, USB charging port. And the device is equipped with one internal rechargeable lithium battery (3.7 V d.c. 500mA) that can be charged directly by external adapter. The device uses beep and vibrate to alert the user to the next step during treatment.
3. Intended Use / Indications for Use
The Intelligence Laser Comb (Model: YTLC001-W) is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.
4. Test Summary
5
The Intelligence LaserComb (Model: YTLC001-W) was evaluated for conformance to recognized international standards. The following is a list of these evaluations and tests that were found to be in conformance:
. Electrical safety test
IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC60601-1-11:2015 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
IEC 60825:2014 Safety of laser products - Part 1: Equipment classification and requirements
. Electromaqnetic compatibility test
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
. Biocompatibility test
ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
. Software verification and validation test
FDA "Guidance for Premarket Submissions and for Software Contained in Medical Devices"
- Software Life Cycle Processes
IEC 62304:2006+AMD1:2015 Medical Device Software
5. Comparison to predicate device and conclusion
The subject device Intelligence LaserComb (Model: YTLC001-W) is substantially equivalent to the predicated device based on intended use, design, specifications and performance. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. Information for predicate device was obtained from publicly available sources. A technical comparison to the predicate is provided below.
| Elements of
| Comparison | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| 510(k) Number | K213789 | K183329 | K193008 |
| Device Name | Intelligence LaserComb | ||
| (YTLC001-W) | Laser Hair Therapy /(Model: | ||
| Recreo 200) | Tricoglam Home USE | ||
| Product Code | OAP | OAP | OAP |
| Regulation Number | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 |
| Regulation Class | II | II | II |
| Prescription | OTC | OTC | Not disclosed |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Reference Device |
| Intended Use | The Intelligence Laser Comb | ||
| (Model: YTLC001-W) is indicated to promote hair growth in males with androgenic alopecia who have | |||
| Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV. | Laser Hair Therapy is indicated to promote hair growth in males with androgenic alopecia who have | ||
| Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV. | Tricoglam Home Use is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have | ||
| Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV | |||
| Type of Laser | Visible red light-emitting diodes | Visible red light-emitting diodes | Visible red LED diodes |
| Wavelength | 655nm±10nm | 655nm±5nm | 650 nm +/- 10 nm |
| Amounts of laser | |||
| diode | 10 | 12 | 105 |
| Energy of Per Laser | |||
| Diode | ≤5mW | ≤5mW | 5mW |
| Pow er intensity | 2.5 mW/cm² | Not disclosed | Not disclosed |
| Dosage intensity | 1.2 J/cm² | Not disclosed | 1.2 J/cm² |
| Classification | |||
| according to | |||
| IEC60825-1 | Class 3R | Class 3R | Not disclosed |
| Treatment Time | 8 minutes per treatment | 8 minutes per treatment | 20 minutes |
| Treatment Frequency | 3 times per week (every other day) | 3 times per week (every other day) | Continuous every day |
| Applicable People | Norwood Hamilton IIa-V (males) | ||
| Ludwig-Savin I-4, II-1, II-2, or frontal (females) | Norwood Hamilton IIa-V (males) | ||
| Ludwig-Savin I-4, II-1, II-2, or frontal (females) | Ludwig-Savin Classification s I - II(females); Norwood Hamilton Classification s IIa - V (males). | ||
| Applicable Skin | Fitzpatrick Skin Phototypes I-IV | Fitzpatrick Skin Phototypes I-IV | Fitzpatrick Skin Phototypes I-IV |
| Appearance Design | Comb | Comb | Helmet |
| Safety and | |||
| Performance Feature | Complied with IEC 60601-1, IEC 60601-1-2, IEC60601-1- 11,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, IEC 62471, IEC 60601-2-57, IEC 60601-1-11 |
| Biocompatibility | All patient contacting materials are complied with ISO 10993-5, ISO 10993-10 | All patient contacting materials are complied with ISO 10993-1, ISO 10993-5 | All patient contacting materials are complied with ISO 10993-1, ISO 10993-5 |
6
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Performance Data:
The following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the Intelligence LaserComb (Model: YTLC001-W) was conducted in accordance with the ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, as recognized by FDA.
The battery of testing was performed to, and passed, including:
ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity,
ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- Electrical and EMC Safety
Electrical safety and EMC safety testing was performed to, and passed, the following standards:
IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC60601-1-11:2015 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
IEC 60825:2014 Safety of laser products - Part 1: Equipment classification and requirements
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
Summary for clinical test
Clinical performance is not deemed necessary.
Conclusion
Based on the above performance as documented in this application, Intelligence Laser Comb (Model: YTLC001-W) was found to have a safety and effectiveness profile that is similar to the predicate devices. Thus, the subject device is substantially equivalent to the predicate devices.