(64 days)
Not Found
No
The device description and performance studies focus on the physical properties of light emission and heating, with no mention of AI or ML algorithms for data processing, decision-making, or personalized treatment.
Yes
The device is intended to provide temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles, which are all therapeutic effects.
No
The device is described as providing "topical heating" for "temporary relief of minor muscular and joint pain and stiffness," and "temporary relaxation of muscles." These are all therapeutic applications, not diagnostic ones.
No
The device description explicitly states it is a "hand held device" with physical components like LEDs, heating plates, an applicator, and a power adaptor, indicating it is a hardware device, not software-only.
Based on the provided information, the HeatLux Pro I device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing topical heating for temporary relief of pain, stiffness, muscle spasm, and temporary increase in local blood circulation and muscle relaxation. This is a therapeutic use, not a diagnostic one.
- Device Description: The device description details a hand-held device using LEDs and heating plates to apply energy to the skin. This aligns with a physical therapy or pain relief device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The HeatLux Pro I device's function is to apply energy to the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
HeatLux Pro I 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 temperary relief of minor muscular and joint pan and stiffness, minor arthritis pam or muscle spasm, the temporary increase in local and blood carculation, and temporary relaxation of muscles.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The HeatLux Pro I device is a hand held device, using low power light spectrum, array of 24 LEDs, at wavelength of 630+/-10nm, combined with four metal heating plates (temperature stabilized to 41%). The HeatLux Pro I device consists of an applicator and an AC/DC power adaptor. The applicator is a hand held unit used for treatment, as the treatment surface at the applicator tip comes in direct contact with the skin.
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 Use
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)
Non-Clinical (Bench) Performance Data: A set of bench tests were performed to evaluate the thermal profile and temperature stability of the HeatLux Pro I device and to compare them to the thermal profile and temperature stability of the HeatLux 1 device. The results of the bench tests demonstrated that the HeatLux Pro I device has the same thermal profile and temperature stability properties as those reported for the predicate device.
Pre-Clinical (Animal Study) Performance Data: Not Applicable
Clinical Performance Data: Not Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2015
Home Skinovations Ltd. % Ms. Ahava Stein A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Street, Suite 102 Kfar Saba 4442520 Israel
Re: K150175
Trade/Device Name: HeatLux Pro I Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: March 1, 2015 Received: March 6, 2015
Dear Ms. Stein:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K150175
Device Name HeatLux Pro I
Indications for Use (Describe)
HeatLux Pro I 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 temperary relief of minor muscular and joint pan and stiffness, minor arthritis pam or muscle spasm, the temporary increase in local and blood carculation, and temporary relaxation of muscles.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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FORM FDA 3881 (8/14)
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Section 6:
Special 510(k) Summary
4
510(K) SUMMARY
HEATLUX PRO I DEVICE
510(k) Number K_
Applicant Name:
| Company Name: | Home Skinovations Ltd. |
|---|---|
| Address: | Tavor Building, POB 533 |
| Yokneam Iillit 2069206 Israel | |
| Tel: +972(4)9097440 | |
| Fax: +972(4)9097471 | |
| E-mail: ahava@asteinrac.com |
Contact Person:
| Official Correspondent: | Ahava Stein |
|---|---|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| Address: | 20 Hata'as Str., Suite 102 |
| Kfar Saba 4442520 Israel | |
| Tel: +972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-mail: ahava@asteinrac.com | |
| Date Prepared: | January 22, 2015 |
| Trade Name: | HeatLux Pro I device |
| Classification Name: | CFR Classification section 890.5500; (Product code ILY) |
| Classification: | Class II Medical Device |
Predicate Device:
The HeatLux Pro I device is substantially equivalent to the previously cleared, HeatLux 1 device, also manufactured by Home Skinovations Ltd.
| Device | Manufacturer | 510(k) No. |
|---|---|---|
| HeatLux 1 | Home Skinovations Ltd. | K120582 |
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Device Description:
The HeatLux Pro I device is a hand held device, using low power light spectrum, array of 24 LEDs, at wavelength of 630±10nm, combined with four metal heating plates (temperature stabilized to 41%). The HeatLux Pro I device consists of an applicator and an AC/DC power adaptor. The applicator is a hand held unit used for treatment, as the treatment surface at the applicator tip comes in direct contact with the skin.
Device Specifications:
Maximal heating plates output power: 12W Maximal optical power density: 10mWatts/cm2 Package dimensions: 22cm x 22cm x 14cm Weight: 250gr Main Line Frequency (nominal): 50-60 Hz Input Voltage (nominal): 100-240 VAC
Intended Use/Indication for Use:
The HeatLux Pro I device 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 stiffhess, minor arthritis pain or muscle spasm, the temporary increase in local and blood circulation, and temporary relaxation of muscles.
Performance Standards:
The HeatLux Pro I device has been tested and complies with the following voluntary recognized standards:
- IEC 60601-1, (Third Edition, 2005 / 2006), Medical Electrical Equipment Part ● 1: General requirements for basic safety and essential performance
- IEC 60601-1-2. (Third Edition, 2007), Medical Electrical Equipment Part 1-2: ● General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests
- . IEC 60601-2-57, (First Edition, 2011), IEC 60601-2-57 (2011), Medical Electrical Equipment - Part 2-57: Particular Requirements for The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesthetic Use.
Non-Clinical (Bench) Performance Data:
A set of bench tests were performed to evaluate the thermal profile and temperature stability of the HeatLux Pro I device and to compare them to the thermal profile and temperature stability of the HeatLux 1 device.
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The results of the bench tests demonstrated that the HeatLux Pro I device has the same thermal profile and temperature stability properties as those reported for the predicate device.
Pre-Clinical (Animal Study) Performance Data:
Not Applicable
Clinical Performance Data:
Not Applicable
Substantial Equivalence:
The indications for use and technological characteristics of the HeatLux Pro I device are substantially equivalent to the indications for use and technological characteristics of the HeatLux 1 device.
The design and components in the HeatLux Pro I device, including the wall adaptor and the applicator are similar to the design and components found in the predicate HeatLux 1 device. The battery was replaced with the direct adaptor charger for longer operation time and in order to increase the device life time. The differences do not negatively affect the safety or efficacy of the device as supported by the results of the performance tests. The performance specifications of the HeatLux Pro I device are substantially equivalent to those in the HeatLux 1 device. The safety features and compliance with safety standards in the HeatLux Pro I device are similar to the safety features and compliance with safety standards found in the HeatLux 1 device. Patient contact materials were partly modified and tested for biocompatibility. Any differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the new HeatLux Pro I device underwent performance testing, including software validation testing and electrical and mechanical safety testing according to IEC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2 and bench tests. These performance tests demonstrated that the differences in the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Consequently, it can be concluded that the HeatLux Pro I device is substantially equivalent to the predicate HeatLux 1 device, cleared under 510(k) K120582.
Conclusions:
Based on the performance testing and comparison to predicate device, the HeatLux Pro I device is substantially equivalent to the HeatLux 1 predicate device for the abovementioned Intended Use/Indication for Use.