Sound Vaser System
FDA 510(k) K991791 · Sound Surgical Technologies, LLC
510(k) numberK991791
Submission
- Device name
- Sound Vaser System
- Applicant
- Sound Surgical Technologies, LLC
Lafayette, CO, US - Received
- May 25, 1999
- Decision date
- August 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFL – Instrument, Ultrasonic Surgical
- Device class
- Unclassified
Other 510(k)s with product code LFL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261448 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | Misonix, LLC | 07/30/2026SE |
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 10/08/2025SE |
| K242894 | SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic…LFL · Traditional | Shanghai Saints Sages Surgical Co., Ltd. | 06/18/2025SE |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000)LFL · Traditional | Stryker Instruments | 03/24/2025SE |
| K241700 | Tenex 2nd Generation SystemLFL · Traditional | Trice Medical, Inc. | 11/18/2024SE |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 07/11/2024SE |
| K233036 | Ultrasonic Surgical SystemLFL · Traditional | Hunan Handlike Minimally Invasive Surgery Co.… | 06/18/2024SE |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 07/11/2023SE |
| K231117 | neXus Ultrasonic Surgical Aspirator SystemLFL · Special | Misonix, LLC, A Bioventus Company | 06/23/2023SE |
| K221790 | HARMONIC 700 ShearsLFL · Traditional | Ethicon Endo-Surgery, LLC | 02/28/2023SE |
More from Ethicon Endo-Surgery, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K120328 | Origins Lipoharvesting SystemMUU · Traditional | 09/17/2012SE |
| K110306 | Sound Surgical Vaser 2.1 Lipo SystemQPB · Traditional | 06/23/2011SE |
| K110255 | Sound Surgical Technologies LLC Powerx Lipo SystemQPB · Traditional | 04/04/2011SE |
| K022051 | Soundvaser SystemQPB · Traditional | 09/11/2002SE |
| K993868 | The Soundvaser Dissection SystemLFL · Traditional | 12/21/1999SE |
Questions and answers
When was Sound Vaser System cleared by the FDA?
Sound Vaser System (K991791) received a 510(k) decision of Substantially Equivalent on August 12, 1999, 79 days after the submission was received.
What is the product code of K991791?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.