The ID-510 iRestore Elite is indicated to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.

Device Description

The ID-510 iRestore Elite is a low-level laser/light system operating at 680 ± 10, 655 ± 10, and 625± 10 nanometers. The physical configuration is that of a helmet containing an inner and outer liner, stabilized with a silicone pad lined fixation ring. The device helmet is constructed of an ABS type plastic. The system operates on line voltage at 100 or 240 volts. The helmet's inner liner permits full adjustment to any heads of non-toxic silicone pads. The helmet contains 300 units of five-millwatt-diode lasers and 200 units of fivemilliwatt, super luminescent diodes, that emit red light. This system delivers fixed laser emission levels, measured to be 2500 total millwatts per 12 minute treatment session, which cannot be altered by the operator.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ID-510 iRestore Elite device, which is an infrared lamp for promoting hair growth. The document focuses on demonstrating substantial equivalence to a predicate device (ID-500 iRestore Hair Growth System) rather than providing specific acceptance criteria and detailed study results for the ID-510 iRestore Elite itself.

The document lists non-clinical performance data (e.g., cytotoxicity, electrical safety, software verification) that were performed to support substantial equivalence. However, it does not detail a clinical study with acceptance criteria for device performance based on hair growth outcomes in human subjects, nor does it refer to an AI algorithm that would typically have the detailed study requirements you've requested.

Therefore, I cannot provide the information you asked for regarding:

A table of acceptance criteria and reported device performance related to hair growth.
Sample size used for a test set, data provenance, or expert involvement for ground truth, as these typically relate to the validation of a diagnostic or AI-driven device's performance.
Number of experts, their qualifications, or adjudication methods for establishing ground truth on a test set.
MRMC comparative effectiveness study results or effect sizes for human readers with/without AI assistance.
Standalone (algorithm-only) performance.
Detailed type of ground truth beyond the general claim of "safety and effectiveness" through non-clinical tests.
Sample size for the training set or how ground truth for a training set was established, as this implies a machine learning model, which is not described.

The information provided solely pertains to the non-clinical tests performed to demonstrate the ID-510 iRestore Elite's safety and effectiveness for substantial equivalence, not its direct clinical efficacy against quantified hair growth metrics under specific acceptance criteria.

The document states:

"To demonstrate safety and effectiveness of ID-510 iRestore Elite and to show substantial equivalence to the predicate device, Remax Medi-Tech (Shenzhen) Corporation completed the following non-clinical tests."
"Results confirm that the design inputs and performance specifications for the device are met."
"The ID-510 iRestore Elite passed the testing in accordance with internal requirements, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:"

The tests listed are:

Cytotoxicity testing per ISO 10993-5: Passed
Sensitization testing per ISO 10993-10: Passed
Electrical safety testing per ANSI AMMI 60601-1: Passed
Electromagnetic Disturbance (EMC) testing per IEC 60601-1-2: Passed
Software verification and validation per FDA Guidance: Compliant
Lifetime Testing: Supports lifetime of five years
Transportation Testing per ASTM D4169: Demonstrates package integrity maintained

This means the acceptance criteria detailed are for these non-clinical engineering and biocompatibility tests, not for a clinical outcome like hair growth percentage or density, and there is no mention of an AI component requiring a "test set" or "training set" in the context of machine learning.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 13, 2022

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

Re: K222081

Trade/Device Name: ID-510 iRestore Elite Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: July 12, 2022 Received: July 15, 2022

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.

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

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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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K222081

Device Name

ID-510 iRestore Elite

Indications for Use (Describe)

The ID-510 iRestore Elite is indicated to promote hair growth in males who have Norwood-Hamilton Classifications of Ila-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.

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 K222081

5.1 Submission Sponsor

Freedom Laser Therapy Inc. 16782 Von Karman Ave, Unit 15 Irvine, CA, 92606 USA Contact: Wei-Chih (Kevin) Chen Title: President

5.2 Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement(@ul.com Contact: Sharon Chen Title: Regulatory Consultant

5.3 Date Prepared

July 12, 2022

5.4 Device Identification

Trade Name:	ID-510 iRestore Elite
Classification Name:	Physical Medicine
Regulation Name:	Infrared Lamp
Regulation Number:	21 CFR 890.5500
Product Code:	OAP
Class:	Class II

5.5 Legally Marketed Predicate Device

Trade Name:	ID-500 iRestore Hair Growth System
510(k) Number:	K213094
Classification Name:	Physical Medicine
Regulation Name:	Infrared Lamp
Regulation Number:	21 CFR 890.5500
Product Code:	OAP
Class:	Class II

5.6 Reference Devices

iRestore Professional 282 (K183417), manufactured by Remax Medi-Tech (Shenzhen) Corporation

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

Theradome LH40 (K180460), manufactured by Theradome, Inc.

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5.7 Indications for Use Statement

5.8 Device Description

5.9 Substantial Equivalence Discussion

The following table compares the ID-510 iRestore Elite to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, 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.

Attribute	ID-510iRestore Elite	ID-500iRestore HairGrowthSystem	iRestoreProfessional282	REVIANRED	TheradomeLH40	Capillus 112,Capillus 244
DeviceCategory	SubjectDevice	PredicateDevice	ReferenceDevice	ReferenceDevice	Reference Device	ReferenceDevice
510(k)Number	Not applicable	K213094	K183417	K173729	K180460	K192012
Manufacturer	Remax Medi-Tech(Shenzhen)Corporation	Remax Medi-Tech(Shenzhen)Corporation	Remax Medi-Tech(Shenzhen)Corporation	PhotonMD,Inc.	Theradome, Inc.	Capillus
Product Code	OAP	OAP	OAP	OAP	OAP	OAP
RegulationNumber	21 CFR890.5500	21 CFR890.5500	21 CFR890.5500	21 CFR890.5500	21 CFR 890.5500	21 CFR890.5500
Indicationsfor Use	The ID-510iRestore Eliteis indicated topromote hairgrowth inmales whohaveNorwood-HamiltonClassifications	The predicateIs indicated totreatandrogeneticalopecia inmenIt isdesigned topromote	The iRestoreProfessional282is indicatedfor promotehair andgrowth infemales withto androgenetichair alopecia	REVIAN REDis indicated totreatAndrogenetichair Alopeciain promotegrowthmaleswho haveNorwood-Hamilton	The TheradomeLH40(Theragrow) is anover the counterand (OTC)hair therapeuticin deviceto treatAndrogeneticAlopecia	The CapillusXand CapillusX+laser domes areintended to treatAndrogeneticAlopecia andpromotion ofhair growth inmales who haveand Norwood
	of IIa-V, and malesin females havewith androgeneticalopecia whohave Ludwig-SavinClassificationsof I-II, and inboth,FitzpatrickClassificationofPhototypesto IV.		who SavinClassificationsof I-II, maleswho have loss andNorwood-HamiltonClassificationsof IIa to V andin Ludwig-SavinClassificationsof I to II. All ofSkin users shouldI alsoSkin Types Ito IV.	ClassificationspromotetreatAndrogeneticAlopeciafor both, growthFitzpatrickClassificationSkin Savin Scale I-1I to I-4, II-1, II-2or frontalpatterns of hair		hair HamiltonClassificationsof IIa - V growth inhave of IIA to Vloss and treatingClassifications ofand IIa to V patternshair of hair loss and toin treatfemales whoand havehair (Savin) Scale 1-in 4. II-1, II-2, orwho frontal; bothSkin Types I to
OTC or Rx Only	OTC	OTC	OTC	OTC	OTC	OTC
Wavelengthof LED	625 ± 10 nmand 655 ± 10 nm	655 ± 10 nm	655 ± 10 nm	620 – 660 nm	No LED	No LED
Wavelengthof Laser	680 ± 10 nm	655 ± 10 nm	655 ± 10 nm	No laser	620 - 660 nm	678 ± 7 nm
Laser PowerforClassification	Laser Class 3R	Laser Class 3R	Laser Class 3R	Not applicable	Laser Class 3R	Laser Class 3R
Time andFrequency ofTreatment	12 minutes pertreatment, to beused daily.	25 minutes pertreatment, to beused every day.	25 minutes pertreatment, to beused other everyday.	10 minutes pertreatment, to beused daily.	20 minutes pertreatment, to beused four timesper week.	Six minutes pertreatment, to beused daily.

Table 5.1: Comparison of Characteristics

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5.10 Non-Clinical Performance Data

To demonstrate safety and effectiveness of ID-510 iRestore Elite and to show substantial equivalence to the predicate device, Remax Medi-Tech (Shenzhen) Corporation completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The ID-510 iRestore Elite passed the testing in accordance with internal requirements, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:

· Cytotoxicity testing per ISO 10993-5 Passed
· Sensitization testing per ISO 10993-10 Passed
· Electrical safety testing per ANSI AMMI 60601-1 Passed
· Electromagnetic Disturbance (EMC) testing per IEC 60601-1-2 Passed
· Software verification and validation per FDA Guidance Compliant
· Lifetime Testing Supports lifetime of five years

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· Transportation Testing per ASTM D4169 Demonstrates package integrity maintained

5.11 Statement of Substantial Equivalence

The ID-510 iRestore Elite has the same indications for use as the ID-500 iRestore Hair Growth System. Any minor differences in the technological characteristics of the subject device when compared to the predicate device have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject device, when compared to the predicate device, does not raise any new questions of safety and effectiveness. Therefore, ID-510 iRestore Elite has been determined to be substantially equivalent to ID-500 iRestore Hair Growth System.

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.