510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844440Substantially Equivalent

Model 4000 Nd:yag Laser for Hemorrhage Control

Cooper Lasersonics, Inc., Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844440 is the FDA 510(k) clearance record for MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL, a class III device, cleared for Cooper Lasersonics, Inc. on under FDA product code LKW (Laser, Neurosurgical). FDA records list 54 510(k) clearances for Cooper Lasersonics, Inc., from to . As of , FDA records show no recalls naming K844440.

Clearance record

Decision date
Received
(174 days to decision)
Product code
LKW Laser, Neurosurgical
Device class
Class III
Review panel
Unknown
Applicant
Cooper Lasersonics, Inc. 3420 Central Expy. ., Santa Clara CA
Third party review
No

Clearances, product code LKW

Trailing 12 months

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

FDA records show no clearances under product code LKW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKW, 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