(126 days)
Not Found
No
The description focuses on the physical design and laser technology, with no mention of AI or ML.
Yes
The device is indicated to treat Androgenetic Alopecia and promote hair growth, which are therapeutic claims.
No
The device description and intended use clearly state that it is a therapy device (low level laser therapy) for promoting hair growth, not for diagnosing any condition.
No
The device description explicitly states it is a "hand-held comb-shaped low level laser therapy device that emits laser light," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat Androgenetic Alopecia and promote hair growth. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a hand-held laser therapy device that emits light to the scalp. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Laser Therapy Hair Growth Comb is indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.
Product codes (comma separated list FDA assigned to the subject device)
OAP
Device Description
Laser Therapy Hair Growth Comb is a hand-held comb-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. Lasercomb-001 contains 7 laser diodes, and Lasercomb-002 contains 9 laser diodes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp
Indicated Patient Age Range
females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
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 following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility Testing: The biocompatibility evaluation for the body-contacting components of Laser Therapy Hair Growth Comb 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 June 16, 2016", as recognized by FDA. The testing was performed to, and passed, including:
- ISO 10993-5:2009/(R)2014, 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
- ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices Part 23: Tests for irritation
- Electrical and EMC Safety: Electrical safety and EMC safety testing was performed to, and passed, the following standards:
- IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- 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
- 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
In addition, testing to IEC 60825-1 certifies the laser system to classification 3R, which is the same as the predicate devices. The battery conforms to IEC 62133.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains two logos. On the left is the Department of Health and Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 12, 2023
Hubei YJT Technology Co.,Ltd % Gamma Zhang RA Manager Tacro Guangzhou Branch Rm. 501, No.55 West Tiyu Rd., Tianhe Dist., Guangzhou Guangdong Guangzhou, Guangdong 510000 China
Re: K230134
Trade/Device Name: Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP
Dear Gamma Zhang:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 23,2023. Specifically, FDA is updating this SE Letter as an administrative correction of incorrect trade name and model name in the 510(k) summary.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jianting Wang, OHT4: Office of Surgical and Infection Control Devices, Acting Assistant Director, jianting.wang@fda.hhs.gov
Sincerely,
Image /page/0/Picture/9 description: The image shows the name "Jianting Wang -S" in a large, sans-serif font. The text is black and appears to be the main subject of the image. The background is a light blue color, which provides contrast to the black text.
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
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized graphic of a human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 23, 2023
Hubei YJT Technology Co.,Ltd % Gamma Zhang RA Manager Tacro Guangzhou Branch Rm. 501, No.55 West Tiyu Rd., Tianhe Dist., Guangzhou Guangdong Guangzhou, Guangdong 510000 China
Re: K230134
Trade/Device Name: Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: April 7, 2023 Received: April 7, 2023
Dear Gamma Zhang:
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.
2
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 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 -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) K230134
Device Name Laser Therapy Hair Growth Comb
Indications for Use (Describe)
Laser Therapy Hair Growth Comb is indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.
Type of Use (Select one or both, as applicable)
| Research involving OFF-Label Substance Use | |
|---|---|
| Investigational use of OFF-Label Substance |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
K230134
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: 2023-05-23
I. Submitter
Hubei YJT Technology Co.,Ltd. Room1-4 , 8F,Block7,Guannan Fuxing Pharmaceutical Park, No.62 Optical Valley Ave, East Lake High-tech Development Zone, Wuhan, Hubei Province, China Tel.: 027-87771565 Hua Xiang (RA engineer) Tel: +86 17364042492 Email: 528149645@qq.com
II. Correspondent Consultant
Tacro Guangzhou Branch Rm. 501, No.55 West Tiyu Rd., Tianhe Dist., Guangzhou, Guangdong Gamma Zhang(RA manager) Tel: +86 13433933949 Email: wbzhang@tacro.cn
III. Device
Type of 510(k): Traditional Common Name: Laser Therapy Hair Growth Comb Trade Name: Laser Therapy Hair Growth Comb Model: Lasercomb-001 & Lasercomb-002 Classification Name: Laser, Comb, Hair Regulation Number: 21 CFR 890.5500 Review Panel: General & Plastic Surgery Regulatory Class: II Product Code: OAP
IV. Predicate Device
| Applicant | Predicate Device | 510(k) Number |
|---|---|---|
| Lexington International, LLC | HairMax LaserComb Advanced 7, HairMax LaserComb Lux 9, Hairmax lasercomb professional 12 | K103368 |
5
510(k)s –Section 6. 510(k) Summary
| Lexington International,
LLC | HairMax LaserComb (Model:
HairMax Advanced 7) | K112524 |
|---------------------------------|--------------------------------------------------|---------|
| Lexington International,
LLC | HairMax LaserComb (Model:
HairMax Lux 9) | K110233 |
V. Device Description
Laser Therapy Hair Growth Comb is a hand-held comb-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. Lasercomb-001 contains 7 laser diodes, and Lasercomb-002 contains 9 laser diodes.
VI. Indications for Use
Laser Therapy Hair Growth Comb is indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) 1-4, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV..
6
VII.Comparison of Technological Characteristics With the Predicate Device
Laser Therapy Hair Growth Comb raises no safety or efficacy concerns when compared to the predicate devices.
A technical comparison to the predicate is provided below:
| Comparison
| Elements | Subject Device | Predicate Device I | Predicate Device II |
|---|---|---|---|
| K Number | K230134 | K103368 | K112524 |
| Trade name | Laser Therapy Hair | ||
| Growth Comb | HairMax LaserComb Advanced | ||
| 7 | HairMax LaserComb Advanced | ||
| 7 | |||
| Model | Lasercomb-001 | HairMax LaserComb Advanced | |
| 7 | HairMax LaserComb Advanced | ||
| 7 | |||
| Classification | |||
| name | Infrared Lamp | Infrared Lamp | Infrared Lamp |
| Product code | OAP | OAP | OAP |
| Intended | |||
| use/Indications | |||
| for Use | Laser Therapy Hair | ||
| Growth Comb is indicated | |||
| to treat Androgenetic | |||
| Alopecia, and promote | |||
| hair growth in females | |||
| who have Ludwig (Savin) | |||
| I-4, II-1, II-2, or frontal | |||
| patterns of hair loss and in | |||
| males who have Norwood | |||
| Hamilton Classifications | |||
| of Ila to V and who both | |||
| have Fitzpatrick Skin | |||
| Types I to IV. | The HairMax LaserComb | ||
| Advanced 7, Lux9, and the | |||
| Professional 12 models are | |||
| indicated to treat androgenetic | |||
| alopecia, promote hair growth | |||
| and help prevent further hair | |||
| loss in males who have | |||
| Norwood Hamilton | |||
| Classifications of Ila to V and | |||
| who both have Fitzpatrick Skin | |||
| Types I to IV. | The HairMax LaserComb | ||
| Advanced 7 is indicated to treat | |||
| androgenetic alopecia | |||
| and promote hair growth in | |||
| females who have Ludwig | |||
| (Savin) Scale I-4, II-1, II-2, or | |||
| frontal and Fitzpatrick Skin | |||
| Types I to IV. | |||
| Location for use | OTC application | OTC application | OTC application |
| Type of laser | Visible red light-emitting | ||
| diodes | Visible red light-emitting diodes | Visible red light-emitting diodes | |
| Wavelength | 650nm ± 10nm | 650nm ± 10nm | 650nm ± 10nm |
| Amount of laser | |||
| diodes | 7 | 7 | 7 |
| Energy of per | |||
| laser diode | 4.63 mW, 4.56 mW, 4.66 | ||
| mW, 4.78 mW, 4.86 mW, | |||
| 4.78 mW, 4.89 mW ISO 10993-5:2009/(R)2014, 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
-
ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices Part 23: Tests for irritation
2)Electrical and EMC Safety
Electrical safety and EMC safety testing was performed to, and passed, the following standards:
-
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
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
-
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
In addition, testing to IEC 60825-1 certifies the laser system to classification 3R, which is the same as the predicate devices.
The battery conforms to IEC 62133.
Summary
Based on the above performance as documented in this application, Laser Therapy Hair Growth Comb was found to have a safety and effectiveness profile that is same as the predicate device.
VIII. 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, Laser Therapy Hair Growth Comb is to be concluded same to its predicate devices.