HeatLux is over the counter hand held device intended to emit energy in the visible and near IR spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local and blood circulation, and temporary relaxation of muscles.

Device Description

HeatLux is a hand held device battery operated that uses low power light spectrum, LED, at wavelength of 645 ±10 nm, combine with tip temperature stabilizer at 41°C. The emitting optical power is in a uniform distribution with no hot spots.

AI/ML Overview

The provided 510(k) summary for the HeatLux device (K120582) describes primarily bench testing for performance verification and does not mention a clinical study with human participants. Therefore, an in-depth analysis of acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, or comparative effectiveness studies (MRMC) for clinical outcomes is not available from this document.

However, based on the information provided, here's a breakdown of the available details:

1. Acceptance Criteria and Reported Device Performance

The document describes bench testing to ensure the device performs as intended with regard to temperature.

Acceptance Criteria (Implied)	Reported Device Performance
Reach idle temperature of 41°C	Verified through bench testing
Maintain 41°C over time	Verified through bench testing
Uniform temperature output	Verified through bench testing (thermal camera)

2. Sample Size and Data Provenance

Test Set Sample Size: Not applicable, as detailed clinical testing with a specific "test set" of human subjects is not described. The bench testing involved "multiple body areas and skin types" for thermal camera measurements, but specific participant numbers are not provided.
Data Provenance: The testing was likely conducted in Israel, the country of origin of the manufacturer (Home Skinovations Ltd.). It was retrospective in the sense that it was performed as part of the device development and verification process.

3. Number of Experts and Qualifications

Not applicable. This information is not provided in the context of the bench testing described. Expert involvement for ground truth establishment is typically relevant for clinical studies involving diagnostics or subjective assessments.

4. Adjudication Method

Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies between expert assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The submission focuses on device technical performance (heating capability) and substantial equivalence to predicate devices based on technical specifications and intended use. The document does not describe studies on how human readers (or users) improve with or without AI assistance, as AI is not a component of this device.

6. Standalone Performance Study

A standalone performance bench test was done to verify the device's ability to reach and maintain a target temperature. This is analogous to standalone performance for hardware, ensuring it functions according to specifications.

Test 1: Temperature sensor attached to the metal surface of the device monitored temperature as a function of time.
Test 2: A thermal camera was used to monitor skin temperature and uniformity on multiple body areas and skin types.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" was established by engineering measurements of temperature using sensors and a thermal camera, verifying adherence to the designed temperature output (41°C).

8. Sample Size for the Training Set

Not applicable. This device is a physical therapeutic device, not an algorithm that requires a "training set" of data in the machine learning sense.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set for an algorithm is involved.

Summary

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K120582

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Home Skinovations Ltd. HeatLux

6 2012 JUL

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

Submitter's information

Name:	Home Skinovations Ltd.
Address:	Tavor building, POB 533, Yokneam 20692, Israel.
Contact:	Dr. Amir Waldman VP Regulatory Affairs

Device information

Trade/Proprietary name: HeatLux

Regulation Number: 21 CFR 890.5500

Regulation Name: Infrared lamp

Regulatory Class: Class II

Product Code: ILY

Predicate devices

. Quantum WARP10 Light Delivery system by Quantum Devices Inc. K032229.
HVR Pain Relief Device by HVR LLC, K101716. .
Tanda Restore, by Pharos Life Corporation, K090008. �
LightStim, by LED Intellectual Properties LLC, K083580. ●

Intended use:

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K120582

Device Description& technology comparison to predicate device:

Technology comparison of HeatLux with predicate devices:

	HeatLux	QuantumWARP10	HVR	TandaRestore	LightStim
Wavelengths (nm)	645	650-950	650-950	870	630,660,855,940
Power mW/cm2	60	50-80	50-80	60	50-80
Treatment areacm2	7	10	10	27	37
Type of Energysource	LED	LED	LED	LED	LED
Targeted skintemperature °C	41±2	39-45	39-45	39-43	39-43
Recommendedtreatment time(minutes)	3-5
Patient contactingmaterial	Stainlesssteels17-4PH,Rigid ABS	Rigid ABS	Rigid ABS	Rigid ABS	Rigid ABS

Performance data:

The device complies with the following U.S. Food and Drug Administration performance standards: 21 CFR 1010.

Bench testing summary:

Bench testing preformed in order to verify the HeatLux performance to reach to the idle temperate of 416C and to maintain the temperature over time.

In the first test temperature sensor was attached to the metal surface of the device and monitors the temperature as function of time.

In the second setup a thermal camera was used in order to monitor the skin temperate and uniformity. The measurement was done on multiple body areas and skin types.

Substantial Equivalence:

The HeatLux is substantial equivalent to its predicate device. The data in this 510(k) submission demonstrate that the HeatLux device has compatible output as the predicate devices, and identical intended use. Therefore is substantial equivalent to its predicate devices.

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K 120582

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Based upon an analysis of the overall performance characteristic for the device, Home Skinovations Ltd. believes that no significant differences exit. Therefore the HeatLux should raise no new issues of safety or effectiveness.

June 21, 2012

Date

Dr. Amir Waldman,
VP Regulatory Affairs

Home Skinovations Ltd.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Home Skinovations Limited % Dr. Amir Waldman Vice President, Regulatory Affairs Tavor Building POB 533 Yokneam Illit, Israel 20692

Re: K120582

Trade/Device Name: HeatLux Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: June 21, 2012 Received: June 26, 2012

Dear Dr. Waldman:

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. 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 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

6 2012 JUL

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Page 2 - Dr. Amir Waldman

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)______________________________________________________________________________________________________________________________________________________

Device Name HeatLux

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number k 120582

Over The Counter Use_X

(Optional Format 1-2-96)

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.