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
K163632Substantially Equivalent

Katalyst Cyclophotocoagulation Probe

Katalyst Surgical, LLC, Chesterfield MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163632 is the FDA 510(k) clearance record for Katalyst Cyclophotocoagulation Probe, a class II device, cleared for Katalyst Surgical, LLC on under FDA product code LQJ (Lens, Surgical, Laser, Accesssory, Ophthalmic Laser). FDA records list 7 510(k) clearances for Katalyst Surgical, LLC, from to . As of , FDA records show no recalls naming K163632.

Clearance record

Decision date
Received
(175 days to decision)
Product code
LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
Katalyst Surgical, LLC 754 Goddard Ave., Chesterfield MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LQJ

Trailing 12 months

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

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