Cleared Traditional

moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager

K152749 · Moor Instruments, Ltd. · Cardiovascular

May 2016

Decision

232d

Days

Class 2

Risk

About This 510(k) Submission

K152749 is an FDA 510(k) clearance for the moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager, a Probe, Blood-flow, Extravascular (Class II — Special Controls, product code DPT), submitted by Moor Instruments, Ltd. (Axminster, GB). The FDA issued a Cleared decision on May 12, 2016, 232 days after receiving the submission on September 23, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2120.

Submission Details

510(k) Number	K152749 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2015
Decision Date	May 12, 2016
Days to Decision	232 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF