(130 days)
Not Found
No
The summary describes a simple light-emitting device with temperature control, and there is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
Yes
The device is intended to provide topical heating for the temporary relief of minor muscular and joint pain, stiffness, and other discomforts, which are therapeutic claims.
No
The device is intended for therapeutic pain relief through heating and increased circulation, not for diagnosing medical conditions.
No
The device description explicitly states it 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." This describes physical hardware components, not a software-only device.
Based on the provided information, the HeatLux device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "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." This describes a therapeutic or physical therapy application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical characteristics of the device (handheld, battery operated, LED light emission, temperature stabilizer). There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD-related information: The document does not mention any of the key aspects of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
In summary, the HeatLux device is a therapeutic device that uses light and heat to provide temporary relief from pain and stiffness. It does not perform any diagnostic tests on samples taken from the body, which is the defining characteristic of an IVD.
N/A
Intended Use / 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.
Product codes
ILY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over the counter
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K032229, K101716, K090008, K083580
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Page 1 of 3
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.
1
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
WARP10 | HVR | Tanda
Restore | 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 area
cm2 | 7 | 10 | 10 | 27 | 37 |
| Type of Energy
source | LED | LED | LED | LED | LED |
| Targeted skin
temperature °C | 41±2 | 39-45 | 39-45 | 39-43 | 39-43 |
| Recommended
treatment time
(minutes) | 3-5 | | | | |
| Patient contacting
material | Stainless
steels
17-4PH,
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
Page 3 of 3
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.
3
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
4
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
5
Page 1 of 1
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)