510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K233076Substantially Equivalent

Laser Speckle Imaging System (RFLSI CZW)

RWD Life Science Co., Ltd., Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233076 is the FDA 510(k) clearance record for Laser Speckle Imaging System (RFLSI CZW), a class II device, cleared for Rwd Life Science Co., Ltd. on under FDA product code DPT (Probe, Blood-Flow, Extravascular). FDA records list one 510(k) clearance for Rwd Life Science Co., Ltd. As of , FDA records show no recalls naming K233076.

Clearance record

Decision date
Received
(245 days to decision)
Product code
DPT Probe, Blood-Flow, Extravascular
Regulation
21 CFR 870.2120
Device class
Class II
Review panel
Cardiovascular
Applicant
Rwd Life Science Co., Ltd. 19f, Bldg. 9a, Vanke Cloud City Iii, Liuxin 4 St.,, Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DPT

Trailing 12 months

FDA records hold no clearances under product code DPT in the trailing twelve months.

FDA records show no clearances under product code DPT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DPT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260