510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864166Substantially Equivalent

25 Watt Carbon Dioxide Medical Laser for Neurology

Weck Surgical Systems, Hauppauge NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864166 is the FDA 510(k) clearance record for 25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY, a class III device, cleared for Weck Surgical Systems on under FDA product code LKW (Laser, Neurosurgical). FDA records list one 510(k) clearance for Weck Surgical Systems. As of , FDA records show no recalls naming K864166.

Clearance record

Decision date
Received
(110 days to decision)
Product code
LKW Laser, Neurosurgical
Device class
Class III
Review panel
Unknown
Applicant
Weck Surgical Systems 686 Old Willets Path, Hauppauge NY
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