ELLIPSE JUVIA, MODEL 9EJU7465

{0}------------------------------------------------ K072023 ## Ellipse A/S SEP 1 2 2007 # Ellipse Juvia laser system This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.87(h) and Part 807.92. #### A. Contact information and device identification: | Date of the summary: | 20 July 2007 | |-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted by/manufacturer: | Ellipse A/S<br>Agern Alle 11<br>2970 Hoersholm, Denmark<br>Tel: + 45 4576 8808<br>Fax: + 45 4517 6851 | | Contact person: | Ole Kofod | | Device Trade Name: | Ellipse Juvia. | | Device Model number: | 9EJU7465. | | Common Name: | Laser treatment system. | | Classification name: | Laser surgical instrument for use in general and plastic surgery and in<br>dermatology (per 21 CFR Part 878.4810). | | Device classification: | Class II. | | Product code: | GEX | | Predicate devices legally<br>marketed to which Ellipse<br>A/S claims equivalence: | • Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and<br>Delivery Device (K022060) manufactured by Lumenis, Inc., Santa<br>Clara, CA, USA.<br>(Laser surgical instrument for use in general and plastic surgery<br>and in dermatology (per 21 CFR Part 878.4810)).<br>• SLIM Evolution Family of CO2 Lasers and Delivery Device Ac-<br>cessories (K063001) manufactured by Lasering S.r.l, Modena, It-<br>aly.<br>(Laser surgical instrument for use in general and plastic surgery<br>and in dermatology (per 21 CFR Part 878.4810)). | #### B. Description of Ellipse Juvia system: The Ellipse Juvia system comprises the following major parts: - A laser console containing a CO2 laser module capable of providing a laser beam having a . wavelength of 10,600 nm. - A scanner that is intended to manipulate and place a pulsed beam received from the laser . console in a pre-specified pattern on the skin being treated. - An optical fiber providing a beam path from the laser to the scanner. . {1}------------------------------------------------ ## C. Intended Use of Ellipse Juvia system: Ellipse Juvia is intended for use in dermatology and plastic surgery for treatment of: - . Skin Resurfacing - · Wrinkles, Rhytides, and Furrows - Acne Scars # D. Comparison of Ellipse Juvia to predicate devices: | Issue/data com-<br>pared | Ellipse Juvia | SLIM<br>(Lasering S.r.l) | Ultrapulse Encore<br>(Lumenis) | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA clearance /<br>status | Being submitted (this<br>submission) | K063001 | K022060 | | Indications | Skin resurfacing,<br>wrinkles, rhytids, and<br>furrows,<br>acne scars | Skin resurfacing,<br>treatment of furrows and<br>wrinkles,<br>acne scars,<br>and others | Skin resurfacing,<br>wrinkles, rhytids, and fur-<br>rows,<br>acne scars,<br>and others | | Technology | The system comprises:<br>a) A laser console con-<br>taining a CO2 laser<br>module<br>b) A scanner for pro-<br>ducing a pattern of<br>light spots on the skin<br>c) a beam delivering<br>system connecting the<br>laser console and the<br>scanner. | The system comprises:<br>a) A laser console contain-<br>ing a CO2 laser module<br>b) A scanner for producing<br>a pattern of light spots on<br>the skin<br>c) a beam delivering sys-<br>tem connecting the laser<br>console and the scanner. | The system comprises:<br>a) A laser console contain-<br>ing a CO2 laser module<br>b) A scanner for producing<br>a pattern of light spots on<br>the skin<br>c) a beam delivering sys-<br>tem connecting the laser<br>console and the scanner. | | Length of beam<br>delivering system | 165cm | 130cm | 150 / 180 cm depending on<br>model | | Type of beam de-<br>livering system | Fiber providing full<br>freedom of movement | Articulated arm with 340°<br>of freedom | Articulated arm with 360°<br>of freedom | | Wavelength | 10,600nm | 10,600nm | 10,600nm | | Max power | 0.11-20W | 0.1-15W, 0.2-30W, 1-50W<br>depending on the model | 1-60W | | Minimum scanner<br>spot size | Ø300µm | Ø400µm | Ø1300µm | | Max power den-<br>sity (computed as<br>max power di-<br>vided by mini-<br>mum scanner spot<br>size) | 20W / Ø300µm =<br>28.6kW/cm2 | 15W / Ø400µm =<br>15.0kW/cm2<br>30W / Ø400µm =<br>30.0kW/cm2<br>50W / Ø400µm =<br>50kW/cm2 | 60W/ Ø1300µm =<br>6kW/cm2 | | Aiming beam | 635nm, max 5mW | 635nm, max. 2mW | 635nm, max 5mW | | Scanning speed<br>(light spots on the<br>skin per second) | 0.3-100 Hz | 1-10,000 Hz | 1-1,000 Hz | | Time for a full<br>scan | In the range of 1 sec –<br>Actual time is depend-<br>ing on scan pattern<br>chosen | In the range of 1 sec – Ac-<br>tual time is depending on<br>scan pattern chosen | In the range of 1 sec – Ac-<br>tual time is depending on<br>scan pattern chosen | | Beam activation | Foot switch | Foot switch | Foot switch | {2}------------------------------------------------ ### Conclusion: Ellipse Juvia applications and indications are evaluated to be within the scope of the previously cleared devices. The same counts for the essential treatment parameters, the protective conditions for the skin during treatment, and the working conditions of the physician. Based on this side-by-side comparison of the overall performance characteristics of the predicate devices under consideration Ellipse A/S concludes that no significant differences exist. The Ellipse Juvia should not raise any new issues of safety and effectiveness and is judged to be substantially equivalent to the mentioned predicate devices. | (Signature) | | |--------------|--| | Ole Kofod | | | (Typed Name) | | | 20-July-2007 | | | (Date) | | # (Premarket Notification 510(k) Number) {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ellipse A/S % Ole Kofod QA/RA Manager Agern Alle 11 DK-2970 Hørsholm Denmark SEP 1 2 2007 Re: K072023 Trade/Device Name: Ellipse Juvia Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 31, 2007 Received: September 7, 2007 Dear Ole Kofod: 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 indicle 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 1 c. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misburanding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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, IDA 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 manufon wour not not hot 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); good manufacturing practice requirements as set {4}------------------------------------------------ Page 2 - Ole Kofod 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 100-1000. This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to 100x) marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 510(k) Notification Device Name: Ellipse Juvia Indications for Use: Ellipse Juvia is intended for use in dermatology and plastic surgery for treatment of: - Skin Resurfacing . - Wrinkles, Rhytides, and Furrows . - Acne Scars . Concurrence of CDRH, Office valuation (ODF Prescription Use X Counter Use Division of General, Restoration Format 1-2-96) (Per 21CFR 801.109) and Neurological Devices 23 510(k) Number