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.

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.

AI/ML Overview

The provided text describes the ID-500 iRestore Hair Growth System and its substantial equivalence to a predicate device, the iRestore Professional 282. However, it does not include detailed acceptance criteria for a device performance study in terms of clinical outcomes (e.g., hair count increase) or a study proving the device meets those clinical criteria. Instead, the document focuses on non-clinical performance data demonstrating safety and electrical/laser compliance.

Therefore, many of the requested elements for a clinical performance study (like sample size for test sets, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not available in this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

The document primarily discusses acceptance criteria related to safety and engineering standards, not clinical efficacy.

Acceptance Criteria (Non-Clinical)	Reported Device Performance
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

2. Sample size used for the test set and the data provenance:
This information is not provided as there is no description of a clinical performance study with a test set of human subjects. The "test set" here refers to the samples used in the non-clinical tests (e.g., cytotoxicity tests would use cell cultures or animal models, electrical safety tests would use the device itself). The document does not specify details about these samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there is no mention of a human-centric performance study where experts would establish a ground truth for clinical outcomes like hair growth. The "ground truth" for the non-clinical tests would be defined by the standards themselves (e.g., a cytotoxicity assay result being below a certain threshold).

4. Adjudication method for the test set:
This information is not applicable for the same reasons as above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device described is a low-level laser/light therapy system for hair growth, not an AI-powered diagnostic tool requiring human reader interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is not an algorithm.

7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by the harmonized standards (ISO, ANSI, IEC, ASTM) and FDA guidance documents that the device was tested against. For example:

Safety standards: Passing specific thresholds for electrical leakage, laser emission limits, or biocompatibility responses.
Software compliance: Adherence to defined software development and validation practices.
Lifetime/Transportation: Meeting predefined engineering specifications for durability and package integrity.

8. The sample size for the training set:
This information is not applicable as the device is a hardware product, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.

Summary of the Study:

The document describes a non-clinical performance study focused on demonstrating the safety and engineering compliance of the ID-500 iRestore Hair Growth System. The study involved testing the device against various national and international standards related to biocompatibility, electrical safety, electromagnetic compatibility, home use environment, laser safety, software validation, product lifetime, and transportation durability. The results of these tests confirmed that the device met the design inputs and performance specifications required by these standards, supporting its safety and effectiveness from an engineering and manufacturing perspective, and its substantial equivalence to the predicate device. No clinical efficacy study or AI-related performance study is detailed in this document.

Summary

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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.

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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.

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

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Indications for Use

510(k) Number (if known) K213094

Device Name ID-500 iRestore Hair Growth System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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) ChenPresidentFreedom Laser Therapy, Inc.16782 Von Karman Ave, Unit 15Irvine, CA 92606 USATelephone: (714) 669-9888Fax: 949-748-8639kevin@freedomlasertherapy.com
Contact:	Sharon ChenRegulatory ConsultantEmergo Global Consulting, LLC2500 Bee Cave Road, Building 1, Suite 300Austin, Texas 78746 United StatesTelephone: (512) 327-9997Fax: (512)327-9998LST.AUS.ProjectManagement@ul.com
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

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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

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,

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	Norwood-HamiltonClassifications of IIa to Vand in females who haveLudgwig-SavinClassifications of I to II.All users should also haveFitzpatrick Skin Types Ito IV.	males who haveNorwood-HamiltonClassifications of IIa-Vand for both,Fitzpatrick Classificationof Skin Phototypes I toIV.
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 forClassification	< 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

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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

Regulation Number and Section

§ 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.