Sound Surgical Technologies, LLC: FDA clearances and approvals
Sound Surgical Technologies, LLC has 6 FDA 510(k) clearances (first 1999, latest 2012), across 3 product codes in 1 review panel. Median 510(k) review time: 79 days. openFDA lists 2 product recalls by a recalling firm named Sound Surgical Technologies, LLC. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 228 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | 3 | 3 |
| LFL | Instrument, Ultrasonic Surgical | 2 | 2 |
| MUU | System, Suction, Lipoplasty | 1 | 1 |
Review panels
Most recent Sound Surgical Technologies, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120328 | ORIGINS LIPOHARVESTING SYSTEM | MUU | 2012-09-17 | 228 |
| K110306 | SOUND SURGICAL VASER 2.1 LIPO SYSTEM | QPB | 2011-06-23 | 141 |
| K110255 | SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM | QPB | 2011-04-04 | 66 |
| K022051 | SOUNDVASER SYSTEM | QPB | 2002-09-11 | 79 |
| K993868 | THE SOUNDVASER DISSECTION SYSTEM | LFL | 1999-12-21 | 36 |
| K991791 | SOUND VASER SYSTEM | LFL | 1999-08-12 | 79 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2010-12-21.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Sound Surgical Technologies, LLC is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01373827: Protocol To Evaluate Patient Measurements After Ultrasonic Treatment (Completed, started 2011-06)
- NCT01260298: Protocol To Evaluate Patient Measurements After Ultrasonic Treatment (Completed, started 2010-12)
- NCT00731354: VASER-Assisted Lipoplasty Compared With Suction-Assisted Lipoplasty (Completed, started 2007-07)
Frequently asked questions
How many FDA 510(k) clearances does Sound Surgical Technologies, LLC have?
Sound Surgical Technologies, LLC has 6 FDA 510(k) clearances (first 1999, latest 2012), across 3 product codes in 1 review panel.
How long does FDA take to clear Sound Surgical Technologies, LLC's 510(k)s?
The median time from FDA receipt to decision across Sound Surgical Technologies, LLC's cleared 510(k)s is 79 days.
What devices does Sound Surgical Technologies, LLC make?
Its most frequent FDA product codes are QPB (System, Suction, Lipoplasty For Removal, 3); LFL (Instrument, Ultrasonic Surgical, 2); MUU (System, Suction, Lipoplasty, 1).
Has Sound Surgical Technologies, LLC had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Sound Surgical Technologies, LLC; the most recent began 2010-12-21. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Sound Surgical Technologies, LLC clearances with predicates and recalls
- Run predicate analysis for product code QPB, Sound Surgical Technologies, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.