ID-500 iRestore Hair Growth System

K213094 · Freedom Laser Therapy, Inc. · OAP · Dec 22, 2021 · Physical Medicine

Device Facts

• Record ID: K213094
• Device Name: ID-500 iRestore Hair Growth System
• Applicant: Freedom Laser Therapy, Inc.
• Product Code: OAP · Physical Medicine
• Decision Date: Dec 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V and in females who have Ludgwig-Savin Classifications of I to II. All users should also have Fitzpatrick Skin Types I to IV.

Device Story

Helmet-based low-level laser/light therapy (LLLT) system; utilizes 655nm (±10nm) laser and LED diodes to promote hair growth; intended for home use by patients; device features adjustable inner liner with silicone pads for head stabilization; operates on 100-240V line voltage; provides non-invasive light exposure to scalp; patient self-administers treatment; output consists of red light emission; benefits include potential stimulation of hair follicles for individuals with androgenetic alopecia.

Clinical Evidence

Bench testing only. Testing included cytotoxicity (ISO 10993-5), irritation/sensitization (ISO 10993-10), electrical safety (ANSI AAMI ES60601-1), electromagnetic disturbance (IEC 60601-1-2), home use environment (IEC 60601-1-11), laser safety (IEC 60825-1), software verification/validation, product lifetime (5 years), and transportation testing (ASTM D4169-16).

Technological Characteristics

Helmet form factor with silicone pad fixation; 655nm (±10nm) laser and LED diodes; 5mW power per diode; Class 3R laser; AC powered (100-240V); non-sterile; reusable; software-controlled operation.

Indications for Use

Indicated for men and women with androgenetic alopecia. Males: Norwood-Hamilton IIa-V. Females: Ludwig-Savin I-II. Fitzpatrick Skin Types I-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

• iRestore Professional 282 (K183417)

Reference Devices

• REVIAN RED (K173729)
• LaserCap Family of Lasers 300, 224, 120 & 80 (K203826)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 22, 2021

Freedom Laser Therapy, Inc. % Sharon Chen Regulatory Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K213094

Trade/Device Name: ID-500 iRestore Hair Growth System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: September 23, 2021 Received: September 24, 2021

Dear Sharon Chen:

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); 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Purva Pandya 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K213094

Device Name ID-500 iRestore Hair Growth System

#### Indications for Use (Describe)

ID-500 iRestore Hair Growth System: iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V and in females who have Ludgwig-Savin Classifications of I to II. All users should also have Fitzpatrick Skin Types I to IV.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

#### 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."

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

# 5. 510(k) Summary

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:

# 5.1 Submitter Information

| Company: | Wei-Chih (Kevin) Chen<br>President<br>Freedom Laser Therapy, Inc.<br>16782 Von Karman Ave, Unit 15<br>Irvine, CA 92606 USA<br>Telephone: [phone]<br>Fax: [phone]<br>[e-mail] |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sharon Chen<br>Regulatory Consultant<br>Emergo Global Consulting, LLC<br>2500 Bee Cave Road, Building 1, Suite 300<br>Austin, Texas 78746 United States<br>Telephone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Summary Prepared: | September 23, 2021 |
| 5.2 Name of the Device | |
| Trade Name: | ID-500 iRestore Hair Growth System |
| Common Name: | Lamp, non-heating, for promotion of hair growth |
| Classification Name: | General and Plastic Surgery |
| Review Panel: | Physical Medicine (SU) |
| Regulation: | 890.5500 |
| Class: | Class II |
| Product Code: | OAP |

# 5.3 Equivalence Claimed to Predicate Device

The ID-500 iRestore Hair Growth Systemis equivalent to the iRestore Professional 282 (K 183417), manufactured by Remax Medi-tech (Shenzhen) Corporation.

# 5.4 Reference Devices

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

REVIAN RED (K173729), manufactured by PhontonMD, Inc.

LaserCap Family of Lasers 300, 224, 120 & 80 (K203826), manufactured by Laser Cap Company

## 5.5 Indication for Use Statement

ID-500 iRestore Hair Growth System: iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V and in females who have Ludgwig-Savin Classifications of I to II. All users should also have Fitzpatrick Skin Types I to IV.

### 5.6 Device Description

The ID-500 iRestore Hair Growth System are two low-level laser/light systems operating at different wavelengths. The ID-500 iRestore Hair Growth System consists of laser and LED operating at 655 ± 10 nanometers. The physical configuration of the device is that of a helmet containing an inner and outer liner, stabilized with a silicone pad lined fixation ring. The systems operate on line voltage at 100 or 240 volts. The helmet's inner liner permits full adjustment to any head shape by means of non-toxic silicone pad. The helmet contains 5-millwatt-diode lasers and 5-milliwatt, super luminescent diodes, that emit red light.

## 5.7 Substantial Equivalence Discussion

The following table compares the ID-500 iRestore Hair Growth System to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

| Table 5.1: Comparison of Characteristics | | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | ID-500 iRestore Hair Growth System | Predicate Device |
| 510(k) Number | N/A | K183417 |
| Product Code | OAP | OAP |
| Regulation Number | 21 CFR 890.5500 | 21 CFR 890.5500 |
| Rx/OTC | OTC | OTC |
| Indications for Use | iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have | The iRestore Professional 282 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, |

{5}------------------------------------------------

| | Norwood-Hamilton<br>Classifications of IIa to V<br>and in females who have<br>Ludgwig-Savin<br>Classifications of I to II.<br>All users should also have<br>Fitzpatrick Skin Types I<br>to IV. | males who have<br>Norwood-Hamilton<br>Classifications of IIa-V<br>and for both,<br>Fitzpatrick Classification<br>of Skin Phototypes I to<br>IV. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Wearable Mounting | Helmet design | Helmet design |
| Wavelength of LED | 655 ± 10 nm | 655 ± 10 nm |
| Wavelength of Laser | 655 ± 10 nm | 655 ± 10 nm |
| Laser Power for<br>Classification | < 5mW, Laser Class 3R | < 5mW, Laser Class 3R |
| Sterile | No | No |
| Single-Use | No | No |
| AC Powered | Yes | Yes |

### 5.8 Performance Data

To demonstrate safety and effectiveness of the ID-500 iRestore Hair Growth System and to show substantial equivalence to the predicate device. The ID-500 iRestore Hair Growth System a completed the following nonclinical tests. Results confirm that the design inputs and performance specifications for the device are met. The subject devices passed the testing in accordance with national standards standards shown below, supporting their safety and effectiveness, and their substantial equivalence to the predicate device:

- · Cytotoxicity testing per ISO 10993-5 Passed.
- · Irritation testing per ISO 10993-10 Passed.
- · Sensitization testing per ISO 10993-10 Passed.
- · Electrical safety testing per ANSI AAMI ES60601-1:2005((R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 - Passed.
- · Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 Passed.
- · Home used environment testing per IEC 60601-1-11 Passed.
- · Laser safety testing per IEC 60825-1 Passed.
- · Software verification and validation per FDA Guidance Compliant.
- · Product life time testing Supports life time of 5 years.
- · Transportation testing per ASTM D4169-16 Demonstrates package integrity maintained.

### 5.9 Statement of Substantial Equivalence

The ID-500 iRestore Hair Growth System has the same indications for use as the iRestore Professional 282. Any minor differences in the technological characteristics of the subject devices when compared to the predicate device have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject devices, when compared to the predicate device, does not raise any new

{6}------------------------------------------------

questions of safety and effectiveness. Therefore, the ID-500 iRestore Hair Growth System has been determined to be substantially equivalent to the iRestore Professional 282