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510(k) K233076

Laser Speckle Imaging System (RFLSI CZW) by Rwd Life Science Co., Ltd. — Product Code DPT

K233076 is an FDA 510(k) premarket notification submitted by Rwd Life Science Co., Ltd. for the device "Laser Speckle Imaging System (RFLSI CZW)". The FDA issued a decision of Substantially Equivalent on May 28, 2024. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2024
Date Received
September 26, 2023
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

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  • 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