Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002

K230134 · Hubei Yjt Technology Co.,Ltd · OAP · May 23, 2023 · Physical Medicine

Device Facts

• Record ID: K230134
• Device Name: Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002
• Applicant: Hubei Yjt Technology Co.,Ltd
• Product Code: OAP · Physical Medicine
• Decision Date: May 23, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Hand-held, comb-shaped low-level laser therapy (LLLT) device; emits visible red laser light (650nm) to scalp. Comb teeth part hair to ensure light reaches scalp. Model Lasercomb-001 (7 diodes); Model Lasercomb-002 (9 diodes). Used in home environment by patient (OTC). Treatment involves 15 minutes (001) or 11 minutes (002) per session, 3 times per week. Device provides non-invasive stimulation to promote hair growth. Safety features include compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, and IEC 60825-1 (Class 3R laser).

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5, ISO 10993-10, and ISO 10993-23. Electrical and EMC safety testing performed per IEC 60601-1, IEC 60601-1-11, and IEC 60601-1-2. Laser classification verified per IEC 60825-1 (Class 3R). Battery safety verified per IEC 62133.

Technological Characteristics

Hand-held comb; 650nm ± 10nm visible red laser diodes (7 or 9 diodes); Class 3R laser (IEC 60825-1); battery-powered (IEC 62133); biocompatible materials (ISO 10993-5, 10, 23); IEC 60601-1/1-11/1-2 compliant.

Indications for Use

Indicated for treatment of Androgenetic Alopecia and promotion of hair growth in females (Ludwig/Savin I-4, II-1, II-2, or frontal patterns) and males (Norwood Hamilton IIa to V) with Fitzpatrick Skin Types I to IV.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• HairMax LaserComb Advanced 7 (K103368)
• HairMax LaserComb Lux 9 (K110233)
• HairMax LaserComb (Model: HairMax Advanced 7) (K112524)

Submission Summary (Full Text)

{0}------------------------------------------------

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, [e-mail]

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 [phone] 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

{3}------------------------------------------------

## 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)

| <input type="checkbox"/> | Research involving OFF-Label Substance Use |
|-------------------------------------|--------------------------------------------|
| <input checked="" type="checkbox"/> | Investigational use of OFF-Label Substance |

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

## 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.: [phone] Hua Xiang (RA engineer) Tel: [phone] Email: [e-mail]

#### II. Correspondent Consultant

Tacro Guangzhou Branch Rm. 501, No.55 West Tiyu Rd., Tianhe Dist., Guangzhou, Guangdong Gamma Zhang(RA manager) Tel: [phone] Email: [e-mail]

#### 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,<br>LLC | HairMax LaserComb (Model:<br>HairMax Advanced 7) | K112524 |
|---------------------------------|--------------------------------------------------|---------|
| Lexington International,<br>LLC | HairMax LaserComb (Model:<br>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<br>Elements | Subject Device | Predicate Device I | Predicate Device II |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K230134 | K103368 | K112524 |
| Trade name | Laser Therapy Hair<br>Growth Comb | HairMax LaserComb Advanced<br>7 | HairMax LaserComb Advanced<br>7 |
| Model | Lasercomb-001 | HairMax LaserComb Advanced<br>7 | HairMax LaserComb Advanced<br>7 |
| Classification<br>name | Infrared Lamp | Infrared Lamp | Infrared Lamp |
| Product code | OAP | OAP | OAP |
| Intended<br>use/Indications<br>for Use | Laser Therapy Hair<br>Growth Comb is indicated<br>to treat Androgenetic<br>Alopecia, and promote<br>hair growth in females<br>who have Ludwig (Savin)<br>I-4, II-1, II-2, or frontal<br>patterns of hair loss and in<br>males who have Norwood<br>Hamilton Classifications<br>of Ila to V and who both<br>have Fitzpatrick Skin<br>Types I to IV. | The HairMax LaserComb<br>Advanced 7, Lux9, and the<br>Professional 12 models are<br>indicated to treat androgenetic<br>alopecia, promote hair growth<br>and help prevent further hair<br>loss in males who have<br>Norwood Hamilton<br>Classifications of Ila to V and<br>who both have Fitzpatrick Skin<br>Types I to IV. | The HairMax LaserComb<br>Advanced 7 is indicated to treat<br>androgenetic alopecia<br>and promote hair growth in<br>females who have Ludwig<br>(Savin) Scale I-4, II-1, II-2, or<br>frontal and Fitzpatrick Skin<br>Types I to IV. |
| Location for use | OTC application | OTC application | OTC application |
| Type of laser | Visible red light-emitting<br>diodes | Visible red light-emitting diodes | Visible red light-emitting diodes |
| Wavelength | 650nm ± 10nm | 650nm ± 10nm | 650nm ± 10nm |
| Amount of laser<br>diodes | 7 | 7 | 7 |
| Energy of per<br>laser diode | 4.63 mW, 4.56 mW, 4.66<br>mW, 4.78 mW, 4.86 mW,<br>4.78 mW, 4.89 mW <<br>5mW | 4.71mW, 4.68mW, 4.77mW,<br>4.73mW, 4.89mW, 4.88mW,<br>4.90mW < 5mW | 4.71mW, 4.68mW, 4.77mW,<br>4.73mW, 4.89mW, 4.88mW,<br>4.90mW < 5mW |
| Classification<br>according to<br>IEC60825-1 | Class 3R | Class 3R | Class 3R |
| Treatment time | 15 min per treatment | 15 min per treatment | 15 min per treatment |
| Comparison<br>Elements | Subject Device | Predicate Device I | Predicate Device II |
| Treatment<br>frequency | 3 times per week, spaced<br>out every other day, as<br>little as 16 weeks | 3 times per week, spaced out<br>every other day, as little as 16<br>weeks | 3 times per week, spaced out<br>every other day, as little as 16<br>weeks |
| Applicable<br>people | Norwood-Hamilton<br>IIa~V (males)<br>Ludwig-Savin I~II<br>(females) | Norwood-Hamilton IIa~V<br>(males) | Ludwig-Savin I~II<br>(females) |
| Applicable skin | Fitzpatrick Skin<br>Phototypes I-IV | Fitzpatrick Skin Phototypes<br>I-IV | Fitzpatrick Skin Phototypes<br>I-IV |
| Shape design | Comb | Comb | Comb |
| Safety feature | Complied with<br>IEC60601-1,<br>IEC60601-1-11,<br>IEC60601-1-2<br>and IEC60825-1<br>Complied with<br>IEC 62133<br>(Battery pack) | Complied with<br>IEC60601-1,<br>IEC60601-1-11,<br>IEC60601-1-2 and<br>IEC60825-1<br>Complied with<br>IEC62133 (Battery<br>pack) | Complied with<br>IEC60601-1,<br>IEC60601-1-11,<br>IEC60601-1-2 and<br>IEC60825-1<br>Complied with<br>IEC62133 (Battery<br>pack) |
| Biocompatibility | All body-<br>contacting<br>materials are<br>complied with<br>ISO10993-5 and<br>ISO 10993-10,<br>ISO 10993-23. | All body-contacting<br>materials are<br>complied with<br>ISO10993-5 and ISO<br>10993-10, ISO<br>10993-23. | All body-contacting<br>materials are complied<br>with ISO10993-5 and<br>ISO 10993-10, ISO<br>10993-23. |

For Model: Lasercomb-001

{7}------------------------------------------------

For Model: Lasercomb-002

| Comparison<br>Elements | Subject Device | Predicate Device I | Predicate Device II | |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| K Number | K230134 | K103368 | K110233 | |
| Trade name | Laser Therapy Hair<br>Growth Comb | HairMax LaserComb Lux 9 | HairMax LaserComb Lux 9 | |
| Model | Lasercomb-002 | HairMax LaserComb Lux 9 | HairMax LaserComb Lux 9 | |
| Comparison<br>Elements | ﺭﺍ ﺭﺍﻳﻮﻧﻼﺭ ﺭەﮬﯩﻴﯩﺴﻰ (). ﺭﺍﻳﻮﻧﻼﺭ ﺭﺍﻳﻮﻧﻠﯩﺮﯨﻨﯩﯔ<br>Subject Device | Predicate Device I | Predicate Device II | |
| Classification<br>name | Laser, Comb, Hair | Laser, Comb, Hair | Laser, Comb, Hair | |
| Product code | OAP | OAP | OAP | |
| Intended<br>use/Indications<br>for Use | Laser Therapy Hair<br>Growth Comb is indicated<br>to treat Androgenetic<br>Alopecia, and promote<br>hair growth in females<br>who have Ludwig (Savin)<br>I-4, II-1, II-2, or frontal<br>patterns of hair loss and in<br>males who have Norwood<br>Hamilton Classifications<br>of IIa to V and who both<br>have Fitzpatrick Skin<br>Types I to IV. | The HairMax LaserComb<br>Advanced 7, Lux9, and the<br>Professional 12 models are<br>indicated to treat androgenetic<br>alopecia, promote hair growth<br>and help prevent further hair<br>loss in males who have<br>Norwood Hamilton<br>Classifications of IIa to V and<br>who both have Fitzpatrick Skin<br>Types I to IV. | The HairMax LaserComb Lux 9<br>is indicated to treat androgenetic<br>alopecia and promote hair<br>growth in females who have<br>Ludwig (Savin) Scale I-4, II-1,<br>II-2, or frontal and Fitzpatrick<br>Skin Types I to IV. | |
| Location for use | OTC application | OTC application | OTC application | |
| Type of laser | Visible red light-emitting<br>diodes | Visible red light-emitting diodes | Visible red light-emitting diodes | |
| Wavelength | 650nm±10nm | 650nm±10nm | 650nm±10nm | |
| Amount of laser<br>diodes | 9 | 9 | 9 | |
| Energy of per<br>laser diode | 4.59 mW, 4.67 mW, 4.67<br>mW, 4.77 mW, 4.78 mW,<br>4.81 mW, 4.84 mW, 4.86<br>mW,4.91 mW < 5mW | 4.53mW,4.82mW,4.66mW,<br>4.68mW, 4.87mW, 4.70mW,<br>4.66mW,4.59mW,4.70mW<<br>5mW | 4.53mW,4.82mW,4.66mW,<br>4.68mW,4.87mW,4.70mW,<br>4.66mW,4.59mW,4.70mW<<br>5mW | |
| Classification<br>according to<br>IEC60825-1 | Class 3R | Class 3R | Class 3R | |
| Treatment time | 11 min per treatment | 11 min per treatment | 11 min per treatment | |
| Treatment<br>frequency | 3 times per week, spaced<br>out every other day, as<br>little as 16 weeks | 3 times per week, spaced out<br>every other day, as little as 16<br>weeks | 3 times per week, spaced out<br>every other day, as little as 16<br>weeks | |
| Applicable<br>people | Norwood-Hamilton<br>IIa~V (males)<br>Ludwig-Savin I~II<br>(females) | Norwood-Hamilton IIa~V<br>(males) | Ludwig-Savin I~II<br>(females) | |
| Applicable skin | Fitzpatrick Skin<br>Phototypes I-IV | Fitzpatrick Skin Phototypes<br>I-IV | Fitzpatrick Skin Phototypes<br>I-IV | |
| Shape design | Comb | Comb | Comb | |
| 510(k)s -Section 6. 510(k) Summary | | | | |
| Comparison<br>Elements | Subject Device | Predicate Device I | Predicate Device II | |
| Safety feature | Complied with<br>IEC60601-1,<br>IEC60601-1-11,<br>IEC60601-1-2<br>and IEC60825-1<br>Complied with<br>IEC62133<br>(Battery pack) | Complied with<br>IEC60601-1,<br>IEC60601-1-11,<br>IEC60601-1-2 and<br>IEC60825-1<br>Complied with<br>IEC62133 (Battery<br>pack) | Complied with<br>IEC60601-1,<br>IEC60601-1-11,<br>IEC60601-1-2 and<br>IEC60825-1<br>Complied with<br>IEC62133 (Battery<br>pack) | |
| Biocompatibility | All body-<br>contacting<br>materials are<br>complied with<br>ISO10993-5 and<br>ISO 10993-10,<br>ISO 10993-23. | All body-contacting<br>materials are<br>complied with<br>ISO10993-5 and ISO<br>10993-10, ISO<br>10993-23. | All body-contacting<br>materials are complied<br>with ISO10993-5 and<br>ISO 10993-10, ISO<br>10993-23. | |

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

#### VIII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

#### 1)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

#### 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.