ULTHERA SYSTEM

{0}------------------------------------------------ K122528 1/2 AUG 2 8 2012 ## Attachment 5: 510(k) Summary This 510(k) Summary for the Ulthera System is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) summary. | Applicant: | Ulthera, Inc. | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | 2150 South Country Club Drive, Suite 21<br>Mesa, AZ 85210 | | Contact Person: | Suzon Lommel, VP of Regulatory & Quality Affairs | | Telephone: | 480-649-4069 | | Fax: | 480-619-4071 | | Submission Date: | August 17, 2012 | | Device Trade Name: | Ulthera® System | | Common Name: | Focused Ultrasound Stimulator Use System for Aesthetic Use | | Classification: | Regulatory Class II | | Classification Name: | Focused Ultrasound Stimulator Use System for Aesthetic Use | | Product Code: | OHV | | Legally Marketed | Name: Ulthera® System | | Predicates: | 510(k): #K072505 | | Applicable Guidance: | The Class II Special Controls Guidance Document: Focused Ultrasound Stimulator<br>System for Aesthetic Use was developed in response to Ulthera's DeNovo<br>submission and 510(k) clearance K072505 for the Ulthera System. | | Device Description: | The Ulthera® System consists of the following components:<br>● Ulthera® Control Unit<br>● Handpiece<br>● Transducers | Image /page/0/Picture/6 description: The image shows the word "Ulthera" in a stylized font. The letters are outlined in black, and there are three small circles above the "era" portion of the word. The font appears to be slightly distressed, giving it a textured look. Attachment 5 - 510(k) Summary Page | A5 - 1 {1}------------------------------------------------ 08/17/2012 Indications for Use: The Ulthera" System is indicated for use as a non-invasive dermatological aesthetic treatment to: . lift the eyebrow Description of Change: The proposed change is to extend the current six-month shelf life period to a twelve-month shelf life period for the Ulthera® System Transducers. Performance Data: An accelerated aging study (per ASTM Standard F 1980 (2011)) was conducted to support the shelf life extension of the Ulthera® System Transducers from six months to one year. The results from the tests demonstrate that the technological characteristics and performance criteria of the subject device is comparable to the predicate device. Conclusion: Based on the design, materials, principle of operation, and intended use, the Ulthera® System is substantially equivalent to the legally marketed predicate i device. The Ulthera System Transducers met the predetermined acceptance criteria identified in the performance testing protocol. The results of the twelve-month shelf life study demonstrate that changing the current six-month shelf life period to a twelve-month shelf life period will have no detrimental effect on transducer Therefore, the predicate device is functionality, patient safety or efficacy. substantially equivalent to the subject device. Image /page/1/Picture/10 description: The image shows a logo with the word "uthera" in a stylized font. Above the "era" portion of the word, there are three small circles arranged horizontally. The font appears to be outlined, giving it a distinct look. The logo is simple and clean, with a focus on the unique typography of the word. Attachment 5 - 510(k) Summary {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract eagle or bird-like figure, depicted with flowing lines to represent its wings and body. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Ulthera, Incorporated % Ms. Suzon Lommel VP of Regulatory & Quality Affairs 2150 South Country Club Drive, Suite 21 Mesa, Arizona 85210 Re: K122528 Trade/Device Name: Ulthera® System Regulation Number: 21 CFR 878.4590 Regulation Name: Focused ultrasound stimulator system for aesthetic use Regulatory Class: Class II Product Code: OHV Dated: August 17, 2012 Received: August 20, 2012 Dear Ms. Lommel: 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set AUG 28 2012 {3}------------------------------------------------ ### Page 2 - Ms. Suzon Lommel 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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. Sincerely yours Mark N. Melkerson Mark N. Melk Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure . {4}------------------------------------------------ # Attachment 2: Indications for Use Statement Unknown K122528 510(k) Number: Device Name: Ulthera® System Indications for Use: The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to: lift the eyebrow . Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Neil R. Oslon for mkn Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K122528 Image /page/4/Picture/14 description: The image shows the word "ulthera" in a stylized font. The letters are tall and thin, with a slightly textured or outlined appearance. Above the "era" portion of the word, there are three solid black circles arranged horizontally. The overall impression is a logo or brand name design.