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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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
Combination Product No
PCCP Authorized No
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 47
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K060976.
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K073593 · Deltex Medical Limited · Jan 2009
MOORFLPI FULL-FIELD LASER PERFUSION IMAGER
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MOORLDLS LASER DOPPLER LINE SCANNER
K063561 · Moor Instruments, Ltd. · Jan 2007
DP240 240 HOUR DOPPLER PROBE
K052989 · Deltex Medical · Mar 2006
K060976 · MOORLD12-B1 LASER DOPPLER BURNS IMAGER
Download PDF FDA Summary Moor Instruments, Ltd.