Cleared Traditional

K152749 - moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager

K152749 is an FDA 510(k) clearance for moorLDI2-IR Infrared laser Doppler imager, manufactured by Moor Instruments, Ltd.. The device is a Class 2 Cardiovascular device with product code DPT cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K152749 · Moor Instruments, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
232d
Days
Class 2
Risk

K152749 is an FDA 510(k) clearance for the moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infra.... Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Moor Instruments, Ltd. (Axminster, GB). The FDA issued a Cleared decision on May 12, 2016 after a review of 232 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2120 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Moor Instruments, Ltd. devices

FDA 510(k) Submission Details - K152749

510(k) Number K152749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 125d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPT Device Classification - Class 2, Special Controls

Product Code DPT Probe, Blood-flow, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPT Probe, Blood-flow, Extravascular

All 30
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