Laser Speckle Imaging System (RFLSI CZW)
FDA 510(k) K233076 · Rwd Life Science Co., Ltd.
510(k) numberK233076
Submission
- Device name
- Laser Speckle Imaging System (RFLSI CZW)
- Applicant
- Rwd Life Science Co., Ltd.
Shenzhen, CN - Received
- September 26, 2023
- Decision date
- May 28, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPT – Probe, Blood-Flow, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2120
- Specialty
- Cardiovascular
Other 510(k)s with product code DPT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K163339 | Spectralmd Deepview Wound Imaging System 2.0DPT · Traditional | Spectralmd, Inc. | 08/17/2017SE |
| K152749 | moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser…DPT · Traditional | Moor Instruments, Ltd. | 05/12/2016SE |
| K142932 | Deltex Medical KDP72 Doppler ProbeDPT · Traditional | Deltex Medical Limited | 01/22/2015SE |
| K132730 | Bio-Probe Disposable Insert with; Balance Biosurface, Carmeda Bioactive Surface…DPT · Traditional | Medtronic, Inc. | 05/30/2014SE |
| K133903 | Bio-Probe Transducer (Adult)DPT · Traditional | Medtronic, Inc. | 04/10/2014SE |
| K132163 | Moorldls-Bi Laser Doppler Burns ImagerDPT · Traditional | Moor Instruments, Ltd. | 01/29/2014SE |
| K124049 | Deepview Digital Video Physiological Portable Imaging SystemDPT · Traditional | Spectralmd, Inc. | 04/18/2013SE |
| K123216 | Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm), Aimago Easy Ldi Stand…DPT · Traditional | Aimago SA | 02/07/2013SE |
| K122943 | MOORFLPI-2 Full-Field Laser Perfusion ImagerDPT · Traditional | Moor Instruments, Ltd. | 01/03/2013SE |
| K121429 | Aimago Easyldi Microcirculation CameraDPT · Traditional | Aimago SA | 08/10/2012SE |
Questions and answers
When was Laser Speckle Imaging System (RFLSI CZW) cleared by the FDA?
Laser Speckle Imaging System (RFLSI CZW) (K233076) received a 510(k) decision of Substantially Equivalent on May 28, 2024, 245 days after the submission was received.
What is the product code of K233076?
The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.