(191 days)
The proposed intended use of the Lightfusion™ LED system is to emit energy in the RED and Near Infra-Red (NIR) regions of the spectrum and is indicated for the treatment of periorbital wrinkles.
The LIGHTFUSION™ LED system is a table top, portable phototherapy device whose purpose is to produce an even, cool, narrow-band of light for the treatment periorbital wrinkles. The system consists of a main body or controller that controls the 3 LED face pads. The controller switches the LEDs ON/OFF and controls power to the face pads. The controller contains a timer display consisting of a Dot matrix display. The controller contains software that monitors the face pad temperature via thermistors within the face pads contain the light emitting diodes (LEDs). The LEDs generate the light. The LEDs emit light energy in the red and near infrared light wavebands with peak wavelengths of 630nm +/-10nm, NIR: 830nm +/-17.5nm (Spectral range: Red 620-640nm, NIR 812.5-847.5nm). The therapy heads are designed to be placed over the forehead, sides of the face and chin. The power supply is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The power cable is connected to the controller by a standard coaxial connector. The face pads are connected to the controller by individual connectors that are sealed within the controller and cannot be removed by the user. The face pads contain a temperature sensor (thermistor) that feeds the temperature back to the controller. The equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent. LIGHTFUSION Light emitting diode (LED) system emits light energy in the red and near infra-red (NIR) region of the light spectrum and is intended to treat periorbital wrinkles through a non-thermal mechanism of Photobiomodulation. Photobiomodulation is a form of light therapy that utilizes non ionizing forms of light sources such as LEDs, in the visible and near infrared spectrum. It is a non thermal process involving endogenous chromophores eliciting photophysical and photochemical events at various biological scales.
This document is a 510(k) premarket notification for a medical device called the "LIGHTFUSION LED System." It seeks to demonstrate that the device is substantially equivalent to a legally marketed predicate device, "Young Again LED mask (K124064)."
The key takeaway is that this document does NOT describe clinical studies or acceptance criteria based on clinical performance of the device. Instead, it focuses on demonstrating substantial equivalence through non-clinical performance and safety data, as well as by comparing technological characteristics with the predicate device.
The document explicitly states: "Since the LIGHTFUSION™ LED system raises no new questions in terms of safety and efficacy clinical data is not required." This means there are no "acceptance criteria" related to a quantitative, clinical assessment of device effectiveness in terms of, for example, reduction in wrinkle severity, as might be found in a clinical trial.
Therefore, I cannot provide the requested information for acceptance criteria and study that proves the device meets them, as described in your prompt, because such a study was explicitly deemed not required for this 510(k) submission.
However, I can extract information related to the non-clinical performance and safety criteria the device did meet:
1. A table of acceptance criteria and the reported device performance
Since no clinical performance acceptance criteria or clinical study results are presented, the "acceptance criteria" here relate to compliance with regulatory standards for safety and non-clinical performance.
| Acceptance Criteria Category | Specific Criteria/Standard (Implicit Acceptance) | Reported Device Performance (Compliance) |
|---|---|---|
| General Requirements & Safety | Compliance with IEC 60601-1: "Medical Electrical Equipment Part 1 - General Requirements for Basic Safety and essential performance" | The Light fusion LED system complies with IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC/EN 60601-1-2: "Collateral Standard: Electromagnetic Compatibility – Requirements and test." | The Light fusion LED system complies with IEC/EN 60601-1-2. |
| Photobiological Safety | Compliance with EN62471: "Photobiological Safety of Lamps and Lamp Systems" regarding retinal injury, phototoxic effect, or thermal damage. | The results demonstrate that it poses no risk of retinal injury due to phototoxic effect, or the thermal damage mechanism. |
| Usability | Compliance with IEC 62366: "Medical devices - Application of usability engineering to medical devices." | The LIGHTFUSION™ LED System was assessed with regards to usability for compliance with IEC 62366. |
| Software Safety (IEC 62304) | Software safety classification: Class A (lowest risk). | VITAGE LED Ltd has allocated a software safety classification of Class A for the LIGHTFUSION LED system. |
| Software Safety (FDA Level of Concern) | FDA level of concern for device software: Minor. | The level of concern for the device software is: Minor. |
| Biocompatibility | Compliance with ISO 10993 and FDA - Blue Book Memorandum #G95-1. | VITAGE LED Ltd believes that the device is safe and compliant with the requirements of ISO 10993 and FDA - Blue Book Memorandum #G95-1, supported by ISO 10993-1:2009 annex B. |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable for a clinical test set, as no clinical study was conducted. The tests performed are engineering/performance tests on the device itself.
- Data Provenance: The tests are standard-based engineering and safety assessments of the device hardware and software, rather than data collected from human subjects. The details of where these tests were performed (e.g., in-house, by a certified lab) are not provided in this summary, nor is the country of origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts/Qualifications: Not applicable. Ground truth, in the context of clinical device performance (e.g., diagnosis, outcome), was not established because no clinical study was performed. The "ground truth" for the non-clinical tests is adherence to established engineering, safety, and quality standards (e.g., IEC, EN, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. This concept applies to the reconciliation of disagreements among multiple human readers/experts, which was not part of this "non-clinical" performance assessment.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: Not applicable. This device is a light-therapy system, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is not an algorithm for diagnosis or image interpretation. The "performance" is the device's ability to emit light within specified parameters and meet safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground truth: For the non-clinical tests, the "ground truth" is compliance with international and national safety, electrical, software, and biocompatibility standards (e.g., IEC 60601-1, IEC 60601-1-2, EN 62471, IEC 62366, IEC 62304, ISO 10993). There is no "pathology" or "outcomes data" ground truth as no clinical trials were conducted.
8. The sample size for the training set
- Training set sample size: 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
- Training set ground truth: Not applicable, as there is no training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other. The profiles are black and have a flowing, ribbon-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2017
VITAGE LED Ltd. % Sue D'Arcy Consultant iSmart Marketing Services 129 Green Lanes, Wylde Green Sutton Coldfield, B735LT GB
Re: K162556 Trade/Device Name: LIGHTFUSION LED System 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: GEX Dated: February 23, 2017 Received: February 23, 2017
Dear Sue D'Arcy:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
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
510(k) Number (if known) K162556
Device Name LIGHTFUSION LED System
Indications for Use (Describe)
The proposed intended use of the Lightfusion™ LED system is to emit energy in the RED and Near Infra-Red (NIR) regions of the spectrum and is indicated for the treatment of periorbital wrinkles.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5: 510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).
Submitter's Name: VITAGE LED Ltd
Submitter's Address: VITAGE LED Limited, The Pavilion, Josselin Road, Basildon, Essex. SS13 1QB
Phone: +44 (0) 333 014 2434
User Fee Organisation Number: MD6090255
Contact Person: Susan D'Arcy iSMART Marketing Services, 129 Green Lanes, Wylde Green, Birmingham B73 5LT. United Kingdom. Telephone +44 (0) 7880313315
Date Prepared: September 10th 2016
Date updated: March 22™ 2017
Device Trade Name: LIGHTFUSION™ LED System
Device Common name: Light based, non-laser device for wrinkles
Device Classification Information:
| RegulationNumber | Device Classificationname | DeviceClass | ProductCode | ClassificationPanel | Type |
|---|---|---|---|---|---|
| 21 CFR 878.4810 | Laser surgicalinstrument for use ingeneral and plasticsurgery and indermatology | Class 2 | GEX | General &Plastic Surgery | Traditional510 (k) |
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Predicate device
The VITAGE LED system is substantially equivalent to the legally marketed device; Young Again LED mask K124064.
Device Description
The LIGHTFUSION™ LED system is a table top, portable phototherapy device whose purpose is to produce an even, cool, narrow-band of light for the treatment periorbital wrinkles.
The system consists of a main body or controller that controls the 3 LED face pads. The controller switches the LEDs ON/OFF and controls power to the face pads. The controller contains a timer display consisting of a Dot matrix display. The controller contains software that monitors the face pad temperature via thermistors within the face pads contain the light emitting diodes (LEDs). The LEDs generate the light. The LEDs emit light energy in the red and near infrared light wavebands with peak wavelengths of 630nm +/-10nm, NIR: 830nm +/-17.5nm (Spectral range: Red 620-640nm, NIR 812.5-847.5nm). The therapy heads are designed to be placed over the forehead, sides of the face and chin.
The power supply is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The power cable is connected to the controller by a standard coaxial connector. The face pads are connected to the controller by individual connectors that are sealed within the controller and cannot be removed by the user. The face pads contain a temperature sensor (thermistor) that feeds the temperature back to the controller.
The equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent.
LIGHTFUSION Light emitting diode (LED) system emits light energy in the red and near infra-red (NIR) region of the light spectrum and is intended to treat periorbital wrinkles through a non-thermal mechanism of Photobiomodulation. Photobiomodulation is a form of light therapy that utilizes non ionizing forms of light sources such as LEDs, in the visible and near infrared spectrum. It is a non thermal process involving endogenous chromophores eliciting photophysical and photochemical events at various biological scales.
Indications/Intended Use
The proposed intended use of the Lightfusion™ LED system is to emit energy in the RED and Near Infra-Red (NIR) regions of the spectrum and is indicated for the treatment of periorbital wrinkles.
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Technological Characteristics
A comparative review of the VITAGE LIGHTFUSION LED System with the predicate device (Young Again K124064) found that the technologies, mode of operation, and general principles for treatment with this device was substantially equivalent.
Predicate comparison chart
| Property | LIGHTFUSION LEDsystem | K124064Young again LED mask | Significant differences |
|---|---|---|---|
| Device Manufacturer | Vitage LED Ltd | Espansione MarketingSpa | na |
| Device Trade Name | LIGHTFUSION | Young again™ | na |
| 510(K) Number | - | K124064 | na |
| Device Common Name | LIGHTFUSION | Young again™ | na |
| Device Classification name | Laser surgical instrumentfor use in general andplastic surgery inDermatology | Laser surgicalinstrument for use ingeneral and plasticsurgery in Dermatology | Identical |
| Device Product Code | GEX | OHS | Predicate is intended to beused by the consumer.LIGHTFUSION™ is intendedto be used by suitablyqualified professionals.Although the LIGHTFUSIONsystem is NOT a laser themanufacturer thinks this isthe closest applicableclassification name. |
| Device ClassificationFDA | Class II | Class II | Identical |
| Use | Prescriptive | Over the Counter | Predicate is intended to beused by the consumer.LIGHTFUSION™ is intendedto be used by suitablyqualified professionals. |
| Intended use and Indications | The Lightfusion™ LEDsystem is intended to emitenergy in the RED and NearInfra-Red (NIR) regions ofthe spectrum and isindicated for the use in thetreatment of periorbitalwrinkles | The Young again LED maskis an over the counterdevice intended to emitenergy in the red and IRregion of the spectrum foruse in dermatology for thetreatment of periorbitalwrinkles | Identical |
| Property | LIGHTFUSION LED system | K124064Young again LED mask | Significant differences |
| Mechanism of action | Non-thermal light energy inthe red and near infra-red(NIR) region of the lightspectrum is intended totreat periorbital wrinklesthrough aPhotobiomodulatory effect. | Non-thermal light energyin the red and near infra-red (NIR) region of the lightspectrum is intended totreat periorbital wrinklesthrough aPhotobiomodulatoryeffect. | Identical |
| Intended Location of Use | Face | Face | Identical |
| Energy Type | Light emitting diodes | Light emitting diodes | Identical |
| Peak Wavelength (FWHM) | Red: 630nm+/-10nm.NIR: 830nm+/-17.5nm | Red: 634nmNIR:830nm | The output of theLIGHTFUSION™ LED systemis within the predicateswavelength |
| Treatment protocol(Treatment time) | 2 x weekly(10 minutes, 600 seconds)4 weeks | 2 x weekly (10 minutes,600 seconds)4 weeks | Identical |
| Intensity mW/cm² | Red 70mW/cm²NIR 55 mW/cm² | Red 70mW/cm²NIR 55 mW/cm² | Identical |
| Dose J/cm² | Red 42J/cm²NIR 33J/cm² | Red 42J/cm²NIR 33J/cm² | Identical |
| Timers | Device uses a timer andsoftware to controltreatment duration. | Device uses a timer andsoftware to controltreatment duration | Identical |
| Software Controlled | Yes | Yes | Identical |
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Non Clinical Performance & Safety Data:
To demonstrate safety and effectiveness and substantial equivalence the LIGHTFUSION™ LED system has undergone a number of non-clinical performance tests in line with recognised standards in terms of general requirements, biocompatibility, electrical safety and software.
General requirements and safety: The Light fusion LED system complies with IEC 60601-1: "Medical Electrical Equipment Part 1 - General Requirements for Basic Safety and essential performance" and IEC/EN 60601-1-2: Collateral Standard: Electromagnetic Compatibility – Requirements and test.
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The LIGHTFUSION™ LED System has been evaluated against EN62471: Photobiological Safety of Lamps and Lamp Systems" in consideration of maximum possible light exposure to users and the results demonstrate that it poses no risk of retinal injury due to phototoxic effect, or the thermal damage mechanism. LIGHTFUSION™ LED System was assessed with regards to usability for compliance with IEC 62366: Medical devices - Application of usability enqineering to medical devices.
Software: In accordance with IEC 62304: 2006 Medical device Software - software life cycle process Vitage LED Ltd has allocated a software safety classification of Class A for the LIGHTFUSION LED system. The software has also been classified using the FDA level of concern matrix and the level of concern for the device software is: Minor.
Biocompatability: Considering the intended use for the LIGHTFUSION™ LED system Vitage LED Itd believes that the device is safe and compliant with the requirements of ISO 10993 and the FDA - Blue Book Memorandum #G95-1in terms of biocompatibility. This position is supported by ISO 10993-1:2009 annex B.
These non-clinical tests demonstrate that the LIGHTFUSION™ LED system is safe and effective and performs at least as safely and effectively as the legally marketed predicate devices
Substantial Equivalence statement:
The intended use and technological characteristics of the LIGHTFUSION™ LED System are virtually identical to the intended use and technological characteristics of the listed predicate device. Differences between the LIGHTFUSION™ LED System and the predicate device raise no new questions of safety and efficacy and introduce no new risks.
The LIGHTFUSION™ LED System and its predicate device are light based devices that use non thermal red and near infrared light energy to treat periorbital wrinkles by exposing the surface of the skin to red and near infrared light and work through the non-thermal mechanism of photobiomodulation.
The systems share the same general indications for use, wavelengths and similar functional features. Any minor differences have been identified by the manufacturer and these have been negated by non clinical performance testing.
VITAGE LED Ltd believe that the LIGHTFUSION™ LED system demonstrates substantial equivalence to the currently marketed predicate device, Young Again K124064.
Clinical Performance
Since the LIGHTFUSION™ LED system raises no new questions in terms of safety and efficacy clinical data is not required.
§ 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.