Cleared Traditional

K060976 - MOORLD12-B1 LASER DOPPLER BURNS IMAGER

K060976 is an FDA 510(k) clearance for MOORLD12-B1 LASER DOPPLER BURNS 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 351-day FDA review.

K060976 · Moor Instruments, Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2007
Decision
351d
Days
Class 2
Risk

K060976 is an FDA 510(k) clearance for the MOORLD12-B1 LASER DOPPLER BURNS IMAGER. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Moor Instruments, Ltd. (Axminster, Devon, GB). The FDA issued a Cleared decision on March 27, 2007 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K060976

510(k) Number K060976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2006
Decision Date March 27, 2007
Days to Decision 351 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 125d · This submission: 351d
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 31
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K060976.
MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
K122943 · Moor Instruments, Ltd. · Jan 2013
AIMAGO EASYLDI MICROCIRCULATION CAMERA
K121429 · Aimago SA · Aug 2012
PERICAM PSI
K120884 · Perimed AB · Jul 2012
TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
K012747 · Medtronic Perfusion Systems · Sep 2001
MOOORLDI LASER DOPPLER IMAGER
K980383 · Moor Instruments, Ltd. · Apr 1998
ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
K963703 · International Biophysics Corp. · Apr 1998