HEATLUX

K120582 · Home Skinovations , Ltd. · ILY · Jul 6, 2012 · Physical Medicine

Device Facts

• Record ID: K120582
• Device Name: HEATLUX
• Applicant: Home Skinovations , Ltd.
• Product Code: ILY · Physical Medicine
• Decision Date: Jul 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

HeatLux is a handheld, battery-operated device for OTC topical heating. It utilizes LED technology to emit light at 645 nm (±10 nm) to elevate tissue temperature. The device features a tip temperature stabilizer designed to maintain a surface temperature of 41°C (±2°C) with uniform power distribution (60 mW/cm²) to prevent hot spots. Operated by the patient, the device is applied to the skin for 3-5 minute treatment sessions. By providing localized heat, the device aims to increase blood circulation, relax muscles, and provide temporary relief from minor pain and stiffness associated with muscles, joints, or arthritis. The device is constructed with stainless steel (17-4PH) and rigid ABS plastic.

Clinical Evidence

Bench testing only. Testing verified the device's ability to reach and maintain an idle temperature of 41°C. Temperature sensors were attached to the metal surface to monitor temperature over time. Thermal camera imaging was used to verify skin temperature and uniformity across multiple body areas and skin types.

Technological Characteristics

Handheld, battery-operated LED device. Wavelength: 645 nm (±10 nm). Power density: 60 mW/cm². Target skin temperature: 41°C (±2°C). Materials: Stainless steel 17-4PH and rigid ABS. Treatment area: 7 cm². Complies with 21 CFR 1010 performance standards.

Indications for Use

Indicated for OTC use by individuals seeking temporary relief of minor muscular and joint pain, stiffness, minor arthritis pain, muscle spasm, and for temporary increase in local blood circulation and muscle relaxation.

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

• Quantum WARP10 Light Delivery system (K032229)
• HVR Pain Relief Device (K101716)
• Tanda Restore (K090008)
• LightStim (K083580)

Submission Summary (Full Text)

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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:

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.

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K120582

## Device Description& technology comparison to predicate device:

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.

Technology comparison of HeatLux with predicate devices:

| | HeatLux | Quantum<br>WARP10 | HVR | Tanda<br>Restore | LightStim |
|--------------------------------------------|---------------------------------------------|-------------------|-----------|------------------|-------------------------|
| Wavelengths (nm) | 645 | 650-950 | 650-950 | 870 | 630,<br>660,855,<br>940 |
| Power mW/cm2 | 60 | 50-80 | 50-80 | 60 | 50-80 |
| Treatment area<br>cm2 | 7 | 10 | 10 | 27 | 37 |
| Type of Energy<br>source | LED | LED | LED | LED | LED |
| Targeted skin<br>temperature °C | 41±2 | 39-45 | 39-45 | 39-43 | 39-43 |
| Recommended<br>treatment time<br>(minutes) | 3-5 | | | | |
| Patient contacting<br>material | Stainless<br>steels<br>17-4PH,<br>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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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 [phone] or [phone] 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:

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.

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

OR

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)