510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K080525Substantially Equivalent

Cook Odyssey Holmium Laser System, Model 30W

Cook Incorporated, Bloomington IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080525 is the FDA 510(k) clearance record for COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W, a class II device, cleared for Cook Urological, Inc. on under FDA product code GEX (Powered Laser Surgical Instrument). FDA's definition for product code GEX reads: "A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue...". FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K080525.

Clearance record

Decision date
Received
(51 days to decision)
Product code
GEX Powered Laser Surgical Instrument
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cook Urological, Inc. 750 Daniels Way, Bloomington IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GEX

Trailing 12 months
62 clearances under product code GEX in the twelve months to November 2026, September 2026 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code GEX, trailing twelve months
MonthClearances
December 20255
January 20264
February 20266
March 20267
April 20265
May 20268
June 20263
July 20264
August 20264
September 202611
October 20265
November 20260