LYSONIX LIPOPLASTY ACCESS PORT

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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. Lysonix, Inc. Ronald Lagerquist Regulatory Affairs Manager 1170 Mark Ave. Carpinteria, California 93013 June 8, 2021 Re: K980763 Trade/Device Name: Lysonix Lipoplasty Access Port Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: OPB Dear Ronald Lagerquist: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 28, 1998. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov. Sincerely, # Cindy Chowdhury -S Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird-like figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 8 1998 Mr. Ronald F. Lagerquist ·Requlatory Affairs Manager LySonix Incorporated 1170 Mark Avenue Carpinteria, California 93013 K980763 Re : LySonix Lipoplasty Access Port Trade Name: Requlatory Class: II Product Code: MÜÜ Dated: February 25, 1998 February 28, 1998 Received: Dear Mr. Lagerquist: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical ... Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. {2}------------------------------------------------ #### Page 2 - Mr. Lagerquist This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, CoNa M. Witton, Ph.D. a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # INDICATIONS FOR USE Applicant: LySonix, Inc. 510(k) Number: K980763 Device Name: LySonix Lipoplasty Access Port Indications For Use: The LySonix Lipoplasty Access Port is indicated for use as an access portal to the surgical site and to reduce trauma to the incision site caused by removal and re-entry of cannulas during lipoplasty procedures. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Service Evaluation (ODE) Decision Sign-Off era: Restorative Devices Prescription Use Per 21 CFR 801.109 OR Over-the-Counter {4}------------------------------------------------ K980763 MAY 2 8 1998 # 510(k) SUMMARY This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92 Submitted by: Ronald F. Lagerquist Regulatory Affairs Manager LySonix Inc. 1170 Mark Avenue Carpinteria, CA 93013 Telephone: (805) 684-0409 FAX: (805) 684-0170 Date Prepared: February 25, 1998 Device Name: Proprietary Name: LySonix Lipoplasty Access Port Common Name: Suction Lipoplasty System Accessory # Indication for Use: The LySonix Lipoplasty Access Port is indicated for use as an access portal to the surgical site and to reduce trauma to the incision site caused by removal and re-entry of cannulas during lipoplasty procedures during aesthetic body contouring. ## Device Description: The LySonix Lipoplasty Access Port is an instrument access portal designed for use during lipoplasty procedures for aesthetic body contouring. The device is inserted into the incision site and threaded into place. Once in place, the device threads retain the device in place and allow for the insertion of the lipoplasty cannula. The Lipoplasty Access Portal is designed to be substantially equivalent to Endoscopic Access Devices intended to provide access for surgical instruments and to protect the incision site from trauma during repeated insertion of the cannula during surgical procedures. ### Substantial Equivalence: The LySonix Lipoplasty Access is substantially equivalent to the Applied Medical Technologies Endoscopic Access Device.