(79 days)
The LightStim Professional 2-Panel Light System has two (2) interchangeable 2-Panel LED Systems, each mounted on a hands-free, fully articulating arms:
System #1- emitting energy in the visible and IR spectrums intended for use in the treatment of full-face wrinkles.
System #2 - emitting energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.
The LightStim Professional 2-Panel Light System is a portable device that has two (2) separate interchangeable 2-panel treatment heads, each containing 1,130 LEDs. Each treatment heads is attached to a fully retractable and articulating arm with a 42″ reach. Either one of these arms can be attached to the rolling stand for use. There is an on/off switch, and an AC to DC power supply.
The LightStim 2-Panel Light System is intended to be operated only by a person who has been personally trained by Company personnel. Each device includes a detailed Instruction Manual and includes one-on-one training and instruction by Company training staff. That training includes a thorough review of the Instruction Manual for the device and actual one-on-one training on the operation of the device with the end user.
The provided text is a 510(k) summary for the LightStim Professional 2-Panel Light System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable or not available in this type of submission.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable. This submission doesn't present specific performance metrics or acceptance criteria for clinical effectiveness because it's a substantial equivalence filing. The FDA's 510(k) clearance process for this device relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, and raises no new questions of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. No clinical test set or data provenance is detailed for demonstrating performance against acceptance criteria. The submission focuses on comparing the new device's technical specifications to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable / Not provided. No clinical ground truth establishment is described.
4. Adjudication Method:
- Not applicable / Not provided. No adjudication method is described as there is no clinical test set requiring ground truth adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with vs. without AI:
- Not applicable. This device is a light therapy system, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done:
- Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used:
- Not applicable. No ground truth data is presented as it's not a diagnostic device or a study involving clinical outcomes for proving novel effectiveness.
8. The Sample Size for the Training Set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. No training set ground truth to establish.
What the Study (510(k) Submission) Does Prove:
The 510(k) summary focuses on demonstrating substantial equivalence by:
- Device Description:
- The LightStim Professional 2-Panel Light System has two interchangeable 2-panel LED systems, each with 1,130 LEDs, mounted on articulating arms.
- It includes an on/off switch and an AC to DC power supply.
- It is intended to be operated by a person trained by company personnel.
- Intended Use / Indications for Use:
- System #1: Emits energy in the visible and IR spectrums for the treatment of full-face wrinkles.
- System #2: Emits energy in the visible and IR spectrums for topical heating to temporarily relieve minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, temporarily increase local blood circulation, and temporarily relax muscles.
- Technological Characteristics Comparison with Predicate Devices:
- The submission explicitly states that the LightStim Professional 2-Panel Light System has the exact same intended use as the predicate devices (LED Intellectual Properties Light for Wrinkles (K092800), LightStim for Wrinkles (K120775), and Pain Therapy Light (K083580)).
- Crucially, it states that "the predicate devices and the LightStim Professional 2-Panel Light System are all manufactured by the same LED Intellectual Properties, LLC, and they all utilize the exact same LED parts, with the same engineering and same output." This is the primary "proof" for substantial equivalence.
- Performance Testing (Safety):
- The device "results in patient contact with an electrically powered component" and includes an electronic component, therefore it was tested according to:
- 60601-1: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance.
- 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements for Safety and Essential Performance (for electromagnetic compatibility).
- The implication is that these tests demonstrate the device meets accepted safety standards for electrical medical equipment, in line with the predicate devices.
- The device "results in patient contact with an electrically powered component" and includes an electronic component, therefore it was tested according to:
Conclusion of the Submission:
Based on the analysis of safety, indications, intended uses, performance, and technological properties, the submitter concludes that the LightStim Professional 2-Panel Light System raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2015
LED Intellectual Properties LLC Mr. Steve Marchese Chief Executive Officer 16552 Von Karman Avenue Irvine, California 92606
Re: K150098
Trade/Device Name: LightStim Professional 2-Panel Light Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OHS, ILY Dated: January 15, 2015 Received: January 20, 2015
Dear Mr. Marchese:
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
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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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Indications for Use Statement
| 510(k)Number(if known) | K150098 |
|---|---|
| Device Name | LightStim Professional 2-Panel Light |
| Indicationsfor Use | The LightStim Professional 2-Panel Light System has two (2) interchangeable 2-Panel LED Systems, each mounted on a hands-free, fully articulating arms:System #1- emitting energy in the visible and IR spectrums intended for use in the treatment of full-face wrinkles.System #2 - emitting energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles. |
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) |
OR
Over-The-Counter Use X
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510(k) Summary of Safety and Effectiveness
LED Intellectual Properties, LLC.
Device: LightStim Professional 2-Panel Light System
1. General Information
Submitter: LED Intellectual Properties, LLC 16552 Von Karman Ave. Irvine, Ca. 92606
Contact Person: Steve Marchese Office: (949) 502-4088 Mobile: (949) 394-2427 email: steve@lightstim.com
2. Device name and code
Device Proprietary Name: LightStim Professional 2-Panel Light System
Classification Code and name: OHS - Light Based OTC Wrinkles and ILY - Therapeutic Heating
3. Predicate Devices
LED Intellectual Properties Light for Wrinkles (K092800) + LightStim for Wrinkles (K120775) + Pain Therapy Light (K083580)
4. Device Description
The LightStim Professional 2-Panel Light System is a portable device that has two (2) separate interchangeable 2-panel treatment heads, each containing 1,130 LEDs. Each treatment heads is attached to a fully retractable and articulating arm with a 42″ reach. Either one of these arms can be attached to the rolling stand for use. There is an on/off switch, and an AC to DC power supply.
The LightStim 2-Panel Light System is intended to be operated only by a person who has been personally trained by Company personnel. Each device includes a detailed Instruction Manual and includes one-on-one training and instruction by Company training staff. That training includes a thorough review of the Instruction Manual for the device and actual one-on-one training on the operation of the device with the end user.
5. Indications for Use
The LightStim Professional 2-Panel Light System has two (2) interchangeable 2-Panel LED Systems, each mounted on a hands-free, fully articulating arms:
System #1- emitting energy in the visible and IR spectrums intended for use in the treatment of full-face wrinkles.
System #2 - emitting energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor
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muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.
6. Substantial Equivalency
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Not only does the LightStim Professional 2-Panel Light System have the exact same intended use as the predicate devices, moreover, the predicate devices and the LightStim Professional 2-Panel Light System are all manufactured by the same LED Intellectual Properties, LLC, and they all utilize the exact same LED parts, with the same engineering and same output.
7. Performance Testing
Our device LightStim Professional 2-Panel results in patient contact with an electrically powered component therefore; it was tested according to 60601-1: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
Our device LightStim Professional 2-Panel includes an electronic component, and it was tested according to 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety and Essential Performance.
Therefore, takinq into consideration the Table for Substantial Equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the LightStim Professional 2-Panel Light System raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate devices.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.