moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager
FDA 510(k) K152749 · Moor Instruments, Ltd.
510(k) numberK152749
Submission
- Device name
- moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager
- Applicant
- Moor Instruments, Ltd.
Axminster, GB - Received
- September 23, 2015
- Decision date
- May 12, 2016
- 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
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| 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 |
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More from Aimago SA
| 510(k) | Device | Decision |
|---|---|---|
| K132163 | Moorldls-Bi Laser Doppler Burns ImagerDPT · Traditional | 01/29/2014SE |
| K122943 | MOORFLPI-2 Full-Field Laser Perfusion ImagerDPT · Traditional | 01/03/2013SE |
| K112826 | Noorvms-Oxy Tissue Oxygen and Temperture MonitorMUD · Traditional | 10/10/2012SE |
| K102433 | Moorvms-Pres Pressure Cuff ControllerDPW · Traditional | 11/18/2010SE |
| K083082 | MOORVMS-LDF1 and MOORVMS-LDF2 Laser Doppler Perfusion and Temperature MonitorsGEX · Traditional | 01/13/2009SE |
| K060976 | MOORLD12-B1 Laser Doppler Burns ImagerDPT · Traditional | 03/27/2007SE |
| K063586 | Moorflpi Full-Field Laser Perfusion ImagerDPT · Traditional | 01/25/2007SE |
| K063561 | Moorldls Laser Doppler Line ScannerDPT · Traditional | 01/19/2007SE |
| K032841 | Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IRDPT · Traditional | 12/10/2003SE |
| K011070 | DRT4 Laser Doppler Perfusion and Temperature MonitorGEX · Traditional | 11/07/2001SE |
Questions and answers
When was moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager cleared by the FDA?
moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager (K152749) received a 510(k) decision of Substantially Equivalent on May 12, 2016, 232 days after the submission was received.
What is the product code of K152749?
The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.