K151101 is an FDA 510(k) clearance for the Lotus Series 4 Ultrasonic Surgical System & Accessories. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Sra Developments, Ltd. (Ashburton, Devon, GB). The FDA issued a Cleared decision on July 17, 2015, 84 days after receiving the submission on April 24, 2015.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K151101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2015 |
| Decision Date | July 17, 2015 |
| Days to Decision | 84 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL - Instrument, Ultrasonic Surgical |
| Device Class | - |