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510(k) K152749

moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager by Moor Instruments, Ltd. — Product Code DPT

K152749 is an FDA 510(k) premarket notification submitted by Moor Instruments, Ltd. for the device "moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager". The FDA issued a decision of Substantially Equivalent on May 12, 2016. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Moor Instruments, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2016
Date Received
September 23, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Blood-Flow, Extravascular
Device Class
Class II
Regulation Number
870.2120
Review Panel
CV
Submission Type

Other clearances by Moor Instruments, Ltd.

  • K132163 — MOORLDLS-BI LASER DOPPLER BURNS IMAGER (January 29, 2014)
  • K122943 — MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER (January 3, 2013)
  • K112826 — NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR (October 10, 2012)
  • K102433 — MOORVMS-PRES PRESSURE CUFF CONTROLLER (November 18, 2010)
  • K083082 — MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS (January 13, 2009)
  • K060976 — MOORLD12-B1 LASER DOPPLER BURNS IMAGER (March 27, 2007)
  • K063586 — MOORFLPI FULL-FIELD LASER PERFUSION IMAGER (January 25, 2007)
  • K063561 — MOORLDLS LASER DOPPLER LINE SCANNER (January 19, 2007)
  • K032841 — MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR (December 10, 2003)
  • K011070 — DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR (November 7, 2001)

Other clearances for product code DPT

  • K233076 — Laser Speckle Imaging System (RFLSI CZW) (May 28, 2024)
  • K163339 — SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 (August 17, 2017)
  • K142932 — Deltex Medical KDP72 Doppler Probe (January 22, 2015)
  • K132730 — BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE (May 30, 2014)
  • K133903 — BIO-PROBE TRANSDUCER (ADULT) (April 10, 2014)
  • K132163 — MOORLDLS-BI LASER DOPPLER BURNS IMAGER (January 29, 2014)
  • K124049 — DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM (April 18, 2013)
  • K123216 — AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI (February 7, 2013)
  • K122943 — MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER (January 3, 2013)
  • K121429 — AIMAGO EASYLDI MICROCIRCULATION CAMERA (August 10, 2012)

FDA data resources