(79 days)
No
The summary describes a light therapy device with LED panels and articulating arms. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device's operation. The training described is for the user, not the device itself.
Yes
The device is described as "intended for use in the treatment of full-face wrinkles" and "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." These uses clearly indicate a therapeutic purpose.
No
The device is described as providing treatment (e.g., for wrinkles, muscle pain relief) but does not mention any function for diagnosing conditions.
No
The device description explicitly details hardware components such as LED systems, articulating arms, a rolling stand, an on/off switch, and a power supply. The performance studies also mention testing according to standards for "Medical Electrical Equipment," further indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are for the treatment of full-face wrinkles and for providing topical heating for temporary relief of pain, stiffness, and muscle issues. These are therapeutic applications performed directly on the patient's body.
- Device Description: The device is a light system applied externally to the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples in vitro (outside of the living organism). This device operates in vivo (on the living organism).
N/A
Intended Use / 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 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.
Product codes
OHS, ILY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Full-face (for wrinkles), muscles, and joints (for pain relief)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"intended to be operated only by a person who has been personally trained by Company personnel."
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a way that creates a sense of depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
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
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
2
Indications for Use Statement
| 510(k)
Number
| (if known) | K150098 |
|---|---|
| Device Name | LightStim Professional 2-Panel Light |
| 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 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
3
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
4
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.