(157 days)
The LightStim Professional System #3A panel is intended for the treatment of full-face wrinkles.
The LightStim Professional System #3B panel is intended for the treatment of mild to moderate acne.
The LightStim Professional System #4 panel is intended for the treatment of mild to moderate acne.
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.
This document describes the LightStim Professional 2-Panel Light System, a device for treating facial wrinkles and acne. However, it does not contain the specific information required to complete your request about acceptance criteria and a study proving the device meets those criteria. The provided text is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance study results against specific acceptance criteria.
Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily focuses on regulatory approval by demonstrating substantial equivalence to previously cleared devices. It states 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."
The 'Performance Testing' section only mentions conformance to general electrical and electromagnetic compatibility standards (IEC/EN 60601-1 and IEC/EN 60601-1-2) which are related to device safety and essential performance, not clinical effectiveness or specific acceptance criteria for treating wrinkles or acne. No clinical study data or performance metrics against specific efficacy endpoints are provided in this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2015
LED Intellectual Properties LLC Mr. Steve Marchese Chief Executive Officer 16552 Von Karman Avenue Irvine, California 92606
Re: K151336
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, OLP Dated: May 5, 2015 Received: September 16, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151336
Device Name LightStim Professional 2-Panel Light
Indications for Use (Describe)
The LightStim Professional System #3A panel is intended for the treatment of full-face wrinkles.
The LightStim Professional System #3B panel is intended for the treatment of mild to moderate acne.
The LightStim Professional System #4 panel is intended for the treatment of mild to moderate acne.
| 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) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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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 & Chase Marchese Office: (949) 502-4088 Mobile: (714) 924-0492
Emails: Steve@lightstim.com & Chase@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 OLP – OTC Light Based For Acne
3. Predicate Devices
LED Intellectual Properties LLC LightStim Professional 2-Panel Light (K150098), LightStim for Acne + LightStim for Acne Mini (K142246), LightStim For Acne (K131461), LightStim for Wrinkles (K120775)
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 System #3A panel is intended for the use in the treatment of full-face wrinkles
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The LightStim Professional System #3B panel is intended for the use in the treatment of mild to moderate acne.
The LightStim Professional System #4 panel is intended for the use in the treatment of mild to moderate acne.
6. Substantial Equivalency
The LightStim Professional 2- Panel Light System emits visible and/or infrared energy and the intended use is the same as the intended use of the predicate devices. Further, the predicate devices and the LightStim Professional 2-Panel Light System are produced by the same LED Intellectual Properties, LLC, and they utilize LEDs with the similar outputs and technical characteristics
7. Performance Testing
Our device LightStim Professional 2-Panel results in patient contact with an electrically powered component therefore: it was tested for conformance to IEC / EN 60601-1 30 Edition: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
Our device LightStim Professional 2-Panel includes an electronic component, was tested for conformance to IEC / EN 60601-1-2 30 Edition Medical Electrical Equipment – Part 1-2: General Requirements for Safety and Essential Performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
Therefore, taking 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.