LIGHTFUSION LED SYSTEM

K162556 · Vitage Led, Ltd. · GEX · Mar 24, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K162556
• Device Name: LIGHTFUSION LED SYSTEM
• Applicant: Vitage Led, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Portable, table-top photobiomodulation device; emits non-thermal red (630nm) and near-infrared (830nm) light via LED face pads. Operated by qualified professionals in clinical settings. Controller manages LED power, treatment duration via timer, and monitors pad temperature using integrated thermistors. Output is continuous, narrow-band light energy applied to forehead, sides of face, and chin. Healthcare providers use the device to deliver light therapy; intended to reduce periorbital wrinkles through photochemical/photophysical processes. Benefits include non-invasive wrinkle treatment.

Clinical Evidence

No clinical data provided. Substantial equivalence established via non-clinical performance testing, including IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), EN 62471 (photobiological safety), IEC 62366 (usability), and ISO 10993 (biocompatibility).

Technological Characteristics

Table-top phototherapy device; 3 LED face pads; red (630nm) and NIR (830nm) LEDs. Integrated thermistors for temperature monitoring. Software-controlled timer. Power: mains outlet. Biocompatibility per ISO 10993-1. Software safety class A (IEC 62304); FDA level of concern: Minor.

Indications for Use

Indicated for the treatment of periorbital wrinkles in patients.

Regulatory Classification

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.

Predicate Devices

• Young Again LED mask (K124064)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# 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)

#### 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.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

### 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: [phone]

#### User Fee Organisation Number: MD6090255

Contact Person: Susan D'Arcy iSMART Marketing Services, 129 Green Lanes, Wylde Green, Birmingham B73 5LT. United Kingdom. Telephone [phone]

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:

| Regulation<br>Number | Device Classification<br>name | Device<br>Class | Product<br>Code | Classification<br>Panel | Type |
|----------------------|-------------------------------------------------------------------------------------------------|-----------------|-----------------|------------------------------|------------------------|
| 21 CFR 878.4810 | Laser surgical<br>instrument for use in<br>general and plastic<br>surgery and in<br>dermatology | Class 2 | GEX | General &<br>Plastic Surgery | Traditional<br>510 (k) |

{4}------------------------------------------------

### 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.

{5}------------------------------------------------

### 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 LED<br>system | K124064<br>Young again LED mask | Significant differences |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Manufacturer | Vitage LED Ltd | Espansione Marketing<br>Spa | 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 instrument<br>for use in general and<br>plastic surgery in<br>Dermatology | Laser surgical<br>instrument for use in<br>general and plastic<br>surgery in Dermatology | Identical |
| Device Product Code | GEX | OHS | Predicate is intended to be<br>used by the consumer.<br>LIGHTFUSION™ is intended<br>to be used by suitably<br>qualified professionals.<br>Although the LIGHTFUSION<br>system is NOT a laser the<br>manufacturer thinks this is<br>the closest applicable<br>classification name. |
| Device Classification<br>FDA | Class II | Class II | Identical |
| Use | Prescriptive | Over the Counter | Predicate is intended to be<br>used by the consumer.<br>LIGHTFUSION™ is intended<br>to be used by suitably<br>qualified professionals. |
| Intended use and Indications | The Lightfusion™ LED<br>system is intended to emit<br>energy in the RED and Near<br>Infra-Red (NIR) regions of<br>the spectrum and is<br>indicated for the use in the<br>treatment of periorbital<br>wrinkles | The Young again LED mask<br>is an over the counter<br>device intended to emit<br>energy in the red and IR<br>region of the spectrum for<br>use in dermatology for the<br>treatment of periorbital<br>wrinkles | Identical |
| Property | LIGHTFUSION LED system | K124064<br>Young again LED mask | Significant differences |
| Mechanism of action | Non-thermal light energy in<br>the red and near infra-red<br>(NIR) region of the light<br>spectrum is intended to<br>treat periorbital wrinkles<br>through a<br>Photobiomodulatory effect. | Non-thermal light energy<br>in the red and near infra-<br>red (NIR) region of the light<br>spectrum is intended to<br>treat periorbital wrinkles<br>through a<br>Photobiomodulatory<br>effect. | Identical |
| Intended Location of Use | Face | Face | Identical |
| Energy Type | Light emitting diodes | Light emitting diodes | Identical |
| Peak Wavelength (FWHM) | Red: 630nm+/-10nm.<br>NIR: 830nm+/-17.5nm | Red: 634nm<br>NIR:830nm | The output of the<br>LIGHTFUSION™ LED system<br>is within the predicates<br>wavelength |
| Treatment protocol<br>(Treatment time) | 2 x weekly<br>(10 minutes, 600 seconds)<br>4 weeks | 2 x weekly (10 minutes,<br>600 seconds)<br>4 weeks | Identical |
| Intensity mW/cm² | Red 70mW/cm²<br>NIR 55 mW/cm² | Red 70mW/cm²<br>NIR 55 mW/cm² | Identical |
| Dose J/cm² | Red 42J/cm²<br>NIR 33J/cm² | Red 42J/cm²<br>NIR 33J/cm² | Identical |
| Timers | Device uses a timer and<br>software to control<br>treatment duration. | Device uses a timer and<br>software to control<br>treatment duration | Identical |
| Software Controlled | Yes | Yes | Identical |

{6}------------------------------------------------

## 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.

{7}------------------------------------------------

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.