K240007 is an FDA 510(k) clearance for the Solar Compact (G4-1). This device is classified as a System, Gastrointestinal Motility (electrical) (Class II - Special Controls, product code FFX).
Submitted by Laborie Medical Technologies, Corp. (Portsmouth, US). The FDA issued a Cleared decision on May 6, 2024, 125 days after receiving the submission on January 2, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1725.
| 510(k) Number | K240007 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2024 |
| Decision Date | May 06, 2024 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFX - System, Gastrointestinal Motility (electrical) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1725 |