Avologi ENEO

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 26, 2018 Premier North America Inc. % Doris Dong Consultant Shanghai CV Technology Co., Ltd. Room 903 of Dongbao Building No. 19 Dongbao Road, Songjiang Area Shanghai, 201613 Cn Re: K181659 Trade/Device Name: Avologi ENEO 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 Dated: June 13, 2018 Received: June 28, 2018 Dear Doris Dong: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # David Krause -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) #### K181659 Device Name Avologi ENEO Indications for Use (Describe) Avologi ENEO is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X 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 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 [As required by 21 CFR 807.92] #### 1. Submission Information: | 510(k) Number: | K__________ | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: | June 13th, 2018 | | Type of 510(k) Submission: | Traditional | | Basis for 510(k) Submission: | New device | | Applicant / Owner: | Premier North America Inc.<br>3301 SW 42ND ST., FORT LAUDERDALE, FL 33312-6828, USA | | Manufacturer: | Premier Dead Sea Cosmetic Laboratories Ltd.<br>Shaked Street No. 21 Shoham, Israe | | Submitter / Contact: | Doris Dong (Consultant)<br>Shanghai CV Technology Co., Ltd.<br>Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China<br>E-mail: doris_d@126.com<br>Tel: 86 21-31261348 | #### 2. Device Description: | Proprietary Name: | Avologi ENEO | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Light Emitting Diode (LED) device | | Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology | | Product Code: | OHS | | Device Class: | II | | Regulation Number: | 21 CFR 878.4810 | | Review Panel: | General & Plastic Surgery | | Indications for use: | Avologi ENEO is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. | | Device Description: | Avologi ENEO is a battery operated device that uses low power light spectrum at red and infrared LED, at wavelength of 633±5nm, 830±5nm emitting optical power in a uniform distribution with no hot spots. It is a hand held light emitting diode(LED) device for the treatment of periorbital wrinkles designed for home-use. | #### 3. Predicate Device Identification K110301--Silk'n FX (Home Skinovations Ltd.) -- August 19, 2011 K 152332--Perfectio LED infrared device (OMM IMPORTS INC DBA ZERO GRAVITY) -- January 27, 2015 #### 4. Non-Clinical Test Conclusion Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: * AAMI / ANSI ES60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R) 2012 And A2:2010/(R)2012 {4}------------------------------------------------ (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance * IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests * IEC 60601-1-11 Edition 2.0 2015-01, Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment * IEC 62471 First Edition 2006-07, Photobiological Safety of Lamps and Lamp Systems The patient contact materials in Avologi ENEO are the body housing material of ABS and the head housing material of Stainless steel 304. Both the two materials were tested and found to meet the biocompatibility standards of: * ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process * ISO 10993-5:2009/(R)2014, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity, and * ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity # 5. Substantial Equivalent Based on Assessment of Clinical Performance Data: Clinical data was not including in this submission. | | New Device | Predicate Device | Predicate Device | |-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number: | ------ | K152332 | K110301 | | Product Code: | OHS | OHS | OHS | | Proprietary Name: | Avologi ENEO | Perfectio LED infrared device | Silk'n FX | | Manufacturer: | Premier Dead Sea Cosmetic<br>Laboratories Ltd. | OMM IMPORTS INC DBA<br>ZERO GRAVITY | Home Skinovations Ltd. | | Indications for use: | Avologi ENEO is an over the<br>counter device indicated to<br>emit energy in the red and IR<br>region of the spectrum for use<br>in dermatology for the<br>treatment of periorbital<br>wrinkles. | Perfectio LED infrared device<br>is an over the counter device<br>indicated to emit energy in the<br>red and IR region of the<br>spectrum for use in<br>dermatology for the treatment<br>of periorbital wrinkles. | Silkn FX is an over the counter<br>device indicated to emit energy<br>in the red and IR region of the<br>spectrum for use in<br>dermatology for the treatment<br>of periorbital wrinkles. | | Product pictures: | Image: Avologi ENEO | Image: Perfectio LED infrared device | Image: Silk'n FX | | Handheld | Yes | Yes | Yes | | 3301 SW 42ND ST., FORT LAUDERDALE, FL 33312-6828, USA | | | | | Materials | ABS and stainless steel | ABS and stainless steel | ABS and stainless steel | | product composition | the CHARGING CRADLE, an<br>APPLICATOR and a POWER<br>SUPPLY | the BASE UNIT, an<br>APPLICATOR and an<br>ADAPTER | the BASE UNIT, an<br>APPLICATOR and an<br>ADAPTER | | Wavelengths | 633 ±5nm, 830 ±5nm | 633 ±5nm, 830 ±5nm | 633 ±5nm, 830 ±5nm | | Waveform | Constant | Constant | Constant | | Light source | Light emitting diode(LED) | Light emitting diode(LED) | Light emitting diode(LED) | | light spectrum region | red and IR region of the<br>spectrum | red and IR region of the<br>spectrum | red and IR region of the<br>spectrum | | Energy source | 24 pcs LEDs(12pcs 633nm<br>LEDs+ 12pcs 830nm LEDs )<br>over 15cm² | 25 pcs LEDs(12pcs 633nm<br>LEDs+ 13pcs 830nm LEDs)<br>over 17 cm² | 24 LEDs(12pcs 633nm LEDs+<br>12pcs 830nm LEDs) over 12<br>cm² | | Energy density | 69mW/cm² for 633nm<br>55mW/cm² for 830nm | 70mW/cm² for 633nm<br>55mW/cm² for 830nm | 70mW/cm² for 633nm<br>55mW/cm² for 830nm | | Therapeutic<br>temperature range | 41±2°C / 105.8±35.6°F | 41±2°C / 105.8±35.6°F | 41°C | | Power supply | Adaptor:100~240V AC<br>50/60Hz 2.4A<br>Lithium battery: 3.6Vdc, 2600<br>mAh | Adaptor:100~240V AC<br>50/60Hz 0.2A<br>Lithium battery: 7.4Vd.c.<br>900mAh | Adaptor:100~240V AC<br>50/60Hz 0.4A<br>Lithium battery: 2x3.7V,<br>750±50mAh | | Handpiece charging<br>method | In CHARGING CRADLE | In Base Unit | In Base Unit | | Initial treatment course | For the first month (4 weeks),<br>treatment should be performed<br>3 times a week for 15-20<br>minutes each time (5-7 minutes<br>on each treatment zone). | For the first month (4 weeks),<br>treatment should be performed<br>3 times a week for 15-20<br>minutes each time.(5-7 minutes<br>on each treatment zone). | Week 1, first day (day 1): 20<br>min IR light on each area<br>Two days later (day 3): 20 min<br>RED light on each area<br>Week 2, first day (day 8): 20<br>min IR light on each area<br>Two days later (day 10): 20<br>min RED light on each area<br>Week 3, first day (day 15): 20<br>min IR light on each area<br>Two days later (day 17): 20<br>min RED light on each area<br>Week 4, first day (day 22): 20<br>min IR light on each area<br>Two days later (day 24): 20<br>min RED light on each area | | Maintenance regime | Once a week for 15-20 minutes | Once a week for 15-20 minutes | / | | Target Population | Individuals with periorbita<br>wrinkles | Individuals with periorbital<br>wrinkles | Individuals with periorbital<br>lines and wrinkles | | Anatomical Sites | Periorbital Area | Periorbital Area | Periorbital Area | | Location for use | OTC | OTC | OTC | | Standard meet | IEC60601-1<br>IEC60601-1-2 | IEC60601-1<br>IEC60601-1-2 | IEC60601-1<br>IEC60601-1-2 | | | IEC60601-1-11<br>IEC62471 | IEC60601-1-11<br>IEC62471 | IEC62471 | | Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | Meet FDA's Requirements | ## 6. Substantially Equivalent Comparison Conclusion {5}------------------------------------------------ Premier North America Inc. 3301 SW 42ND ST., FORT LAUDERDALE, FL 33312-6828, USA {6}------------------------------------------------ Premier North America Inc. 3301 SW 42ND ST., FORT LAUDERDALE, FL 33312-6828, USA ## The Conclusions: Taking into consideration the table for substantial equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the proposed device raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate device.