Photonica Professional

{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 image of three human profiles facing right, with the profiles overlapping each other. The profiles are connected to a wing-like shape above them. 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 February 24, 2015 Ward Photonics LLC % Ms. Diane Sudduth Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701 Re: K150336 Trade/Device Name: Photonica Professional 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 6, 2015 Received: February 10, 2015 Dear Ms. Sudduth: 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 510(k) Number (if known) Device Name Photonica Professional Indications for Use (Describe) Photonica Professional is indicated for use in dermatology for the treatment of superticial, benign vascular, and pigmented lesions. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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 PRAStaff(@fda.hhs.gov "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}------------------------------------------------ ## 510(k) Summary ## K150336 ## For # Photonica Professional #### 1. Submission Sponsor Ward Photonics LLC 1980 N. Atlantic Avenue Cocoa Beach, FL 32931 USA Phone: 1-800-392-5950 Fax: 1-800-392-5950 Contact: Terry Ward, Managing Director #### 2. Submission Correspondent Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (512) 818.3811 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Audrey Swearingen, Senior Global Regulatory Consultant Email:_project.management@emergogroup.com #### 3. Date Prepared January 6, 2015 #### 4. Device Identification | Trade/Proprietary Name: | PHOTONICA PROFESSIONAL | |----------------------------|-----------------------------------| | Common/Usual Name: | Laser Powered Surgical Equipment | | Classification Name: | Powered Laser Surgical Instrument | | Classification Regulation: | 878.4810 | | Product Code: | GEX | | Device Class: | Class II | | Classification Panel: | General & Plastic Surgery | ### 5. Legally Marketed Predicate Device(s) The Photonica Professional is substantially equivalent to the Omnilux revive™ manufactured by Photo Therapeutics Ltd and subject of K030426. {4}------------------------------------------------ ## 6. Device Description The Photonica Professional ("Photonica") is a non-invasive red light system with a power output of 105mW/cm , consisting of 150 light emitting diodes (LEDs) that emit visible light at nominal wavelength of 635nm ± 2nm (visible red light spectrum) and a spectral bandwidth of 10nm, for treatment of superficial, benign vascular and pigmented lesions. The components include a mobile pole cart, controller console which plugs into a hospitalgrade isolation transformer (attached with a bracket clamp to the pole cart), LED array mounted on an articulated arm (attached with a bracket clamp to the mobile pole cart), 20 minute timer, on/off switch, and a hospital-grade power cable. The articulated arm allows the light fixture to be positioned in a wide variety of positions. The knuckles and joints on the arm allow the light fixture to be rotated, tilted, and raised/lowered independently. Treatment time is preset to 20 minutes via a validated internal timer delay relay. The light fixture is positioned 17cm (6.8″) from the patient's skin to deliver the standard dose output intensity of 105mW/cm and standard energy dose of 126 J/cm . Photonica does not use any software. ## 7. Indication for Use Statement Photonica is intended for use in dermatology for treatment of superficial, benign vascular and pigmented lesions. ### 8. Substantial Equivalence Discussion The intended use and technological characteristics of this device are identical to the predicate device. The principles of operation and base elements of the device are similar to the predicate device and do not raise different questions of safety and effectiveness than the predicate. See Section 12 – Substantial Equivalence Discussion. | Manufacturer | Photo Therapeutics Ltd | Ward Photonics, LLC | Significant | |----------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------| | Trade Name | Predicate<br>Omnliux revive™ | New Device<br>Photonica Professional | Differences | | 510(k) Number | K030426 | Not assigned | N/A | | Product code | GEX | GEX | N/A | | Regulation<br>Number | 878.4810 | 878.4810 | N/A | | Clinical / Design Features | | | | | Indications for<br>Use | In dermatology for<br>treatment of superficial,<br>benign vascular, and<br>pigmented lesions. | In dermatology for treatment<br>of superficial, benign<br>vascular, and pigmented<br>lesions. | None | | General<br>Design Feature | One LED array | One LED array | None | | Adjustable LED<br>Panel? | Y | Y – articulated arm allows for<br>many adjustments. | None | | Non-invasive? | Y | Y | None | | | | Table 5A - Comparison of Characteristics | |--|--|------------------------------------------| |--|--|------------------------------------------| {5}------------------------------------------------ | Manufacturer | Photo Therapeutics Ltd | Ward Photonics, LLC | Significant | |------------------------------------------------|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Predicate<br>Omnliux revive™ | New Device<br>Photonica Professional | Differences | | Protective<br>Eyewear<br>Included? | Y - one pair for the patient | Y - one pair for the patient;<br>one pair for the operator | Photonica provides<br>operator eyewear for<br>added safety | | | | Head / Lamp Specifications | | | Wavelength | 633±6nm (visible red light<br>spectrum) | 635nm± 2nm (visible red<br>light spectrum) | Similar, + variance is in<br>alignment with the range<br>of both devices | | Bandwidth | 20nm + 3nm | 10nm | Photonica has a narrower<br>specification than the<br>predicate | | Total LED<br>Power Output | 44.7 W + 5W | 240 W | Photonica has more total<br>power, but power is<br>distributed over a larger<br>area such that the output<br>internally and dosage is<br>the same as Omnilux. | | Output<br>intensity/<br>Irradiance<br>(mW/cm²) | 105 mW/cm² | 105 mW/cm² | None | | Recommended<br>Treatment<br>Time<br>(minutes) | 20 minutes | 20 minute | None | | Standard<br>Energy Does<br>(J/cm²) | 126 J/cm² | 126 J/cm² | None | | Typical<br>Coverage Area<br>(cm²) | 803 cm² | 2294 cm² | Similar, spot size is<br>dependent upon number<br>of LEDs and array<br>configuration. | | Head / Lamp<br>Dimensions<br>(cm) | 32 cm x 28 cm | 28.8 cm x 44.5 cm | No functional difference | | Dimensions of<br>Active LED<br>Area (cm) | 15 cm x 28 cm | 22 cm x 38 cm | No functional difference | | Overall Device Specifications | | | | | Unit<br>Dimensions (H<br>x W x D) | 35.5 cm x 17.8 cm x 48 cm | 183.2 cm x 62.2 cm x 61 cm | Omnilux is a tabletop<br>device; the Photonica is a<br>free standing unit on a<br>mobile cart. | | Weight (kg) | 12 kg | 52 kg (with carton) | Photonica includes safety<br>benefit of the isolation<br>transformer which<br>weighs 7.7 kg; size of the<br>Photonica device is larger<br>than the Omnilux. | | Manufacturer | Photo Therapeutics Ltd | Ward Photonics, LLC | Significant | | Trade Name | Predicate<br>Omnliux revive™ | New Device<br>Photonica Professional | Differences | | Electrical Base | 120 VAC, 8.0 amps, 50/60<br>Hz | 100-120 VAC, 3 amps, 50/60<br>Hz | Functionally the same | | Power source | 90V -250V, 8A, 50/60 Hz | 100-120 VAC, 3A, 50/60 Hz | Functionally the same | | Operating<br>Temperature | 10°C to 30°C | +5°C to 35°C | Similar, both comply with<br>IEC 60601-1 safety | | Operating<br>Humidity | 30% to 85% (Relative) | 10% to 90% RH, non-<br>condensing | standard which includes<br>operating temperatures<br>and humidity; both<br>devices are intended for<br>use in the same<br>environmental<br>conditions. | | Cooling<br>Mechanism | Forced air ventilation | Forced air ventilation | None | | Safety<br>features | Unknown | Isolation transformer<br>separates facility power from<br>the device. Power switch<br>cancels the treatment<br>(lowest risk; key switch not<br>required by IEC standards). | Not available for<br>comparison | {6}------------------------------------------------ ## 9. Non-Clinical Performance Data As part of demonstrating safety and effectiveness, Photonica was tested and shown to be in compliance with IEC 62471 for Photobiological Safety of Lamps and Lamp Systems. Testing to the third edition of IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-57 has been conducted and demonstrated that the Photonica device performs according to specifications and functions as intended. Based upon an analysis of the overall performance characteristics for the device, Ward Photonics (hereafter "Ward") believes that Photonica Professional is substantially equivalent to the predicate device. In addition, Ward concludes that the Photonica is substantially equivalent with respect to safety, effectiveness and functionality to the Omnilux revive with the exception of the Photonica does not contain software. ## 10. Clinical Performance Data There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. ## 11. Statement of Substantial Equivalence The Photonica device has the same intended use and technological characteristics as the predicate device, Omnilux revive™, manufactured by Photo Therapeutics Ltd. The information provided in this submission supports the substantial equivalence to the predicate device and that the system is safe and effective for its intended use.