K032424 is an FDA 510(k) clearance for the LOTUS. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Sra Developments, Ltd. (Brookeville, US). The FDA issued a Cleared decision on December 16, 2003, 133 days after receiving the submission on August 5, 2003.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K032424 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2003 |
| Decision Date | December 16, 2003 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL - Instrument, Ultrasonic Surgical |
| Device Class | - |