K233076 is an FDA 510(k) clearance for the Laser Speckle Imaging System (RFLSI CZW). This device is classified as a Probe, Blood-flow, Extravascular (Class II - Special Controls, product code DPT).
Submitted by Rwd Life Science Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 28, 2024, 245 days after receiving the submission on September 26, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 870.2120.
| 510(k) Number | K233076 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2023 |
| Decision Date | May 28, 2024 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | DPT - Probe, Blood-flow, Extravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2120 |