The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

Neurosurgery -
Gastrointestinal and Affiliated Organ Surgery -
Urological Surgery -
Plastic and Reconstructive Surgery -
General Surgery -
-Orthopedic Surgery
Gynecological Surgery -
Thoracic Surgery -
-Laparoscopic Surgery

The SoundVASER System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

Device Description

The SoundVASER System is comprised of an ultrasonic generator (110/120 and 220/240 VAC, 50 & 60 Hz), an ultrasonic surgical handpiece with an ultrasonic surgical probe, and a suction/irrigation subsystem. The ultrasonic surgical handpiece converts electrical energy supplied by the ultrasonic generator into vibratory motion. The vibratory motion is applied to the ultrasonic surgical probe that is attached to the ultrasonic surgical handpiece. The vibratory motion at the tip of the ultrasonic surgical probe fragments and emulsifies contacted soft tissues. The suction/irrigation subsystem is used to remove the fragmented tissues.

AI/ML Overview

The provided text is a 510(k) summary for the SoundVASER System, which outlines its substantial equivalence to predicate devices, rather than presenting a study demonstrating its performance against specific acceptance criteria.

Therefore, the document does not contain information on acceptance criteria, a study proving device performance against those criteria, sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for a test or training set.

The document explicitly states: "The SoundVASER System is similar with regard to design, operation, materials, methods of sterilization, and intended use to the predicate devices indicated above. Therefore, no new safety or efficacy issues are created and the SoundVASER System is substantially equivalent to the predicate devices." This highlights that the submission relies on demonstrating substantial equivalence to already approved devices rather than presenting new performance data against acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".

Sound Surgical Technologies LLC. William Cimino CEO 1300 Plaza Ct. North, #103 Lafayette, Colorado 80026

June 8, 2021

Re: K022051

Trade/Device Name: Soundvaser System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear William Cimino:

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 September 11, 2002. 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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of three human profiles forming a bird-like shape, with the profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 2002

Sound Surgical Technologies LLC William W. Cimino, Ph.D. 1300 Plaza Court, North, #103 Lafayette, Colorado 80026

Re: K022051

Trade/Device Name: Soundvaser System Regulation Number: 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: June21, 2002 Received: June24, 2002

Dear Dr. Cimino:

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. Iisting 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 (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, 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); good manufacturing practice requirements as set 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.

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Page 2 - Dr. William W. Cimino

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 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: The SoundVASER System

Indications for Use:

The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

Neurosurgery -
Gastrointestinal and Affiliated Organ Surgery -
Urological Surgery -
Plastic and Reconstructive Surgery -
General Surgery -
-Orthopedic Surgery
Gynecological Surgery -
Thoracic Surgery -
-Laparoscopic Surgery

The SoundVASER System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Qffice of Device Evaluation (ODE)

Styke Rurdes

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_KOZZ os Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Prescription Use \ (per 2.1 CFR 801.109) (Optional Format 1-2-96)

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SEP 1 1 2002

Sound Surgical Technologies LLC Creating the Perfect Wave ~~~ : :

1300 Plaza Court North, Suite 103, Lafayette, CO 80026 tel 303.926.8608 fax 303.926.8615

510(k) Summary

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is:_025

Submitter

Sound Surgical Technologies LLC 1300 Plaza Court North, #103 Lafayette, Colorado 80026

Contact Person William W. Cimino, Ph.D.

303-926-8608 (TEL) 303-926-8615 (FAX)

Date Prepared June 21, 2002

Proprietary Name SoundVASER System

Common, Usual, or Classification Name Instrument, Ultrasonic Surgical

Classification Class: Class II Panel: 21 CFR 878, General and Plastic Surgery Product Code: LFL, MUU

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K022051 Page 2/3

Predicate Devices

The SoundVASER System is similar in technical design and operation to other surgical systems that utilize ultrasonic frequency vibrating instruments for soft fragmentation and aspiration that the FDA has determined to be substantially equivalent to pre-amendment devices as depicted below:

Sound Surgical Technologies, The SoundVASER System, K991791 ට
Sound Surgical Technologies, The SoundVASER System, K993868 0
Mentor Corporation, The Contour Genesis System, K970471 ם
Mentor Corporation, The Contour Genesis System, K983065 ට
Mentor Corporation, The Contour Genesis System, K004005 D

Device Description

Intended Use

The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

Neurosurgery -
-Gastrointestinal and Affiliated Organ Surgery
-Urological Surgery
Plastic and Reconstructive Surgery -
General Surgery -
Orthopedic Surgery -
-Gynecological Surgery
Thoracic Surgery -
-Laparoscopic Surgery

The SoundVASER is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

Summary of Technological Characteristics

The SoundVASER System is similar with regard to design, operation, materials, methods of sterilization, and intended use to the predicate devices

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K022051 page 3/3

indicated above. Therefore, no new safety or efficacy issues are created and the SoundVASER System is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 878.5040 Suction lipoplasty system.

(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.