ELEMENT-TL

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration." March 15, 2018 ELEMENIC Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt Irvine, California 92620 Re: K180224 Trade/Device Name: ELEMENT-TL 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: January 19, 2018 Received: January 26, 2018 Dear Priscilla Chung: 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 misl eading. 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 of medical device-related adverse events) (21 CFR 803); good {1}------------------------------------------------ manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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, 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) K180224 Device Name ELEMENT-TL ## Indications for Use (Describe) ## 532mm The ELEMENT-TL is indicated for coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lessons angiomas (port wine), telangiectasia (facial or extremities telangiectasias.venous anomalies, leg veins); benien pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneouslesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size). 755 nm The ELEMENT-TL is indicated for stable long-term, or permanent hair reduction which is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I- VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. ## 1064nm The ELEMENT-TL is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), safe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent hair reduction which is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB). | 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ # 510(k) Summary This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: ____March 13, 2018____ #### 1. Applicant / Submitter: ELEMENIC Co., Ltd. 3rd, 34 , Gyeongin-ro 3beon-gil, Bucheon-si, Gyeonggi-do, 14731 Republic of Korea Tel : +82-32-613-5007 Fax : +82-32-613-5009 #### 2. Submission Correspondent: Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine CA 92620 Fax: 714-409-3357 Phone: 714-202-5789 Email: juhee.c@lkconsultinggroup.com #### 3. Device: | Proprietary Name: | ELEMENT-TL | |------------------------------|----------------------------------------------------------------------------------------| | Common Name: | Medical Laser System | | Classification Name: | Laser surgical instrument for use in general and<br>plastic surgery and in dermatology | | Classification: | Class II, 21 CFR 878.4810 | | Classification Product Code: | GEX | #### 4. Predicate Device: ORION by YERIM ENGINEERING Co., Ltd. (K161503) {4}------------------------------------------------ #### 5. Device Description: The subject device is composed of the main body and a handpiece which is an irradiation device and as an accessory part, protective goggles for protection of the worker. This equipment is controlled by a micro-processor interfaced to a LCD touch screen control panel. The computer controls start and stop of the treatment. When the key switch of the system is turned clockwise, the main power will be inputted, which will be conveyed to the hand piece through the control board. Meanwhile, the control board connected to the touch screen is connected to the lamp of the handpiece and controls the same, and controls the whole system through the data connected to the touch screen control panel. When the switch of the hand piece is pressed, the lamp will laser. #### 6. Indications for Use: ## 532nm The ELEMENT-TL is indicated for coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions[angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink): verrucae: skin tags: keratoses: plaques: cutaneouslesion treatment (hemostasis, color lightening, flattening, reduction of lesion size). ## 755 nm The ELEMENT-TL is indicated for stable long-term, or permanent hair reduction which is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I- VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. ## 1064nm The ELEMENT-TL is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte: and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as,but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent hair reduction which is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB). {5}------------------------------------------------ #### Performance Data(Non-Clinical): 7. The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices. - . IEC 60601-1 Medical electrical equipment - part 1: general requirements for basic safety and essential performance - IEC 60601-1-6 Medical electrical equipment part 1-6: general requirements for basic safety . and essential performance - collateral standard: usability. - IEC 62366-1 Medical devices part 1: application of usability engineering to medical devices. . - . IEC 60601-2-22 Medical electrical equipment - part 2-22: particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. (Radiology) - . IEC 60601-1-2 Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests. (General II (ES/EMC)) - . IEC 60825-1 Edition 2.0 2007-03, safety of laser products - part 1: equipment classification. and requirements [including: technical corrigendum 1 (2008), interpretation sheet 1 (2007), interpretation sheet 2 (2007)]. (Radiology) #### 8. Substantial Equivalence The ELEMENIC-TL is substantially equivalent to the ORION by YERIM ENGINEERING Co., Ltd. (K161503). The following comparison table is presented to demonstrate substantial equivalence. | | Subject Device | Primary Predicate Device | | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | Device name | ELEMENT-TL | ORION | | | Manufacturer | ELEMENIC Co., Ltd. | YERIM ENGINEERING<br>Co., Ltd. | | | 510(k) number | K180224 | K161503 | | | Technology | Long Pulse Nd:YAG | Long Pulse Nd:YAG | | | Power (CW Laser) | AC220 - 240 V/16A | AC220 - 240 V/16A | | | Energy<br>(pulse and<br>super pulse) | 1064nm | 100J | 100J | | | 755nm | 50J | 50J | | | 532nm | 10J | 10J | | If pulsed, how is this done | Long pulse | Long pulse | | | Frequency of<br>pulse | 1064 nm | 1Hz | 1Hz | | | 755nm | 3Hz | 3Hz | | | 532nm | 2Hz | 2Hz | | | 1064 nm | 0.1~300ms | 0.1~300ms | | Pulse train duration | 755nm | 0.1~300ms | 0.1~300ms | | | 532nm | 0.1~300ms | 0.1~300ms | | Spot size at target | | 2~20mm | 2~20mm | | Wavelength | | 1064 nm,<br>755nm,<br>532nm | 1064 nm,<br>755nm,<br>532nm | | Aiming beam | | 650nm | 650 nm | | Energy source | | Nd:YAG,<br>Alexandrite,<br>KTP | Nd:YAG,<br>Alexandrite,<br>KTP | | Cooling method | | Cold air | Cold air | | Indications for Use | 532nm<br>The ELEMENT-TL is indicated<br>for coagulation and hemostasis<br>of vascular and cutaneous<br>lesions in dermatology<br>including, but not limited to, the<br>following general categories:<br>vascular lesions[angiomas,<br>hemangiomas (port wine),<br>telangiectasia (facial or<br>extremities<br>telangiectasias, venous<br>anomalies, leg veins)]; benign<br>pigmented lesions (nevi,<br>lentigines, chloasma, cafk-au-<br>lait, tattoos (red and green ink);<br>verrucae; skin tags; keratoses;<br>plaques; cutaneouslesion<br>treatment (hemostasis, color<br>lightening, blanching, flattening,<br>reduction of lesion size).<br>755 nm<br>The ELEMENT-TL is indicated<br>for stable long-term, or<br>permanent hair reduction which<br>is defined as the long-term,<br>stable reduction in the number<br>of hairs regrowing when<br>measured at 6, 9, and 12 months<br>after the completion of a<br>treatment regime. It is used for<br>all skin types (Fitzpatrick I- VI)<br>including tanned skin It is also | 532nm<br>The ORION is indicated for<br>coagulation and hemostasis of<br>vascular and cutaneous lesions<br>in dermatology including, but<br>not limited to, the following<br>general categories: vascular<br>lesions[angiomas,<br>hemangiomas (port wine),<br>telangiectasia (facial or<br>extremities<br>telangiectasias,venous<br>anomalies, leg veins)]; benign<br>pigmented lesions (nevi,<br>lentigines, chloasma, cafk-au-<br>lait, tattoos (red and green<br>ink); verrucae; skin tags;<br>keratoses; plaques;<br>cutaneouslesion treatment<br>(hemostasis, color lightening,<br>blanching, flattening,<br>reduction of lesion size).<br>755 nm<br>The ORION is indicated for<br>stable long-term, or permanent<br>hair reduction which is<br>defined as the long-term,<br>stable reduction in the number<br>of hairs regrowing when<br>measured at 6, 9, and 12<br>months after the completion of<br>a treatment regime. It is used<br>for all skin types (Fitzpatrick<br>I- VI) including tanned skin. It | | {6}------------------------------------------------ {7}------------------------------------------------ | vascular lesions, benign<br>pigmented lesions, and wrinkles. | is also indicated for the<br>treatment of vascular lesions,<br>benign pigmented lesions, and<br>wrinkles. | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1064nm<br>The ELEMENT-TL is intended<br>for the coagulation and<br>hemostasis of benign vascular<br>lesions such as, but not limited<br>to, port wine stains,<br>hemangiomas, warts,<br>telangiectasia, rosacea, venus<br>lake, leg veins, spider veins and<br>poikiloderma of civatte; and<br>treatment of benign cutaneous<br>lesions such as warts, scars,<br>striae and psoriasis. The laser is<br>also intended for the treatment<br>of benign pigmented lesions<br>such as, but not limited to,<br>lentigos (age spots), solar<br>lentigos (sun spots), cafe au lait<br>macules, seborrheic keratoses,<br>nevi, chloasma, verrucae, skin<br>tags, keratoses, tattoos<br>(significant reduction in the<br>intensity of black and/or<br>blue/black tattoos) and plaques.<br>The laser is also indicated for<br>the treatment of wrinkles such<br>as, but not limited to, periocular<br>and perioral wrinkles.<br>Additionally, the laser is<br>indicated for the removal of<br>unwanted hair, for the stable<br>long term, or permanent hair<br>reduction which is defined as the<br>long-term, stable reduction in<br>the number of hairs regrowing<br>when measured at 6, 9, and 12<br>months after the completion of a<br>treatment regime through<br>selective targeting of melanin in<br>hair follicles, and for the<br>treatment of pseudofolliculitis<br>barbae (PFB). | 1064nm<br>The ORION is intended for<br>the coagulation and<br>hemostasis of benign vascular<br>lesions such as, but not limited<br>to, port wine stains,<br>hemangiomas, warts,<br>telangiectasia, rosacea, venus<br>lake, leg veins, spider veins<br>and poikiloderma of civatte;<br>and treatment of benign<br>cutaneous lesions such as<br>warts, scars, striae and<br>psoriasis. The laser is also<br>intended for the treatment of<br>benign pigmented lesions such<br>as,but not limited to, lentigos<br>(age spots), solar lentigos (sun<br>spots), cafe au lait macules,<br>seborrheic keratoses, nevi,<br>chloasma, verrucae, skin tags,<br>keratoses, tattoos (significant<br>reduction in the intensity of<br>black and/or blue/black<br>tattoos) and plaques.<br>The laser is also indicated for<br>the treatment of wrinkles such<br>as, but not limited to,<br>periocular and perioral<br>wrinkles. Additionally, the<br>laser is indicated for the<br>removal of unwanted hair, for<br>the stable long term, or<br>permanent hair reduction<br>which is defined as the long-<br>term, stable reduction in the<br>number of hairs regrowing<br>when measured at 6, 9, and 12<br>months after the completion of<br>a treatment regime through<br>selective targeting of melanin<br>in hair follicles, and for the<br>treatment of pseudofolliculitis<br>barbae (PFB). | In reference to the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and the information provided on the device comparison table and performance test results, the ELEMENIC Co., Ltd. {8}------------------------------------------------ believes that the ELEMENIC-TL is substantially equivalent to the predicate device, ORION (K161503, YERIM ENGINEERING Co., Ltd.). ELEMENT-TL has the same intended use, performance specifications, and similar operational characteristics as the predicate devices. The differences might be in device housing, button locations, and display UI, however, these differences do not raise an issue in safety and performance. And the performance data supports that the device is substantially as safe and effective as the predicate devices for its intended use. Therefore, ELEMENT-TL may be found substantially equivalent to its predicate devices. #### Conclusion: 9. Based on the testing results, ELEMENIC Co., Ltd. concludes that the ELEMENIC-TL is substantially equivalent to the predicate device.