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
K841860Substantially Equivalent

CO2 Surgical Laser System Xml-10

Xanar, Inc., Colorado Springs CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841860 is the FDA 510(k) clearance record for CO2 SURGICAL LASER SYSTEM XML-10, a class II device, cleared for Xanar, Inc. on under FDA product code EWG (Laser, Ent Microsurgical Carbon-Dioxide). FDA records list 11 510(k) clearances for Xanar, Inc., from to . As of , FDA records show no recalls naming K841860.

Clearance record

Decision date
Received
(188 days to decision)
Product code
EWG Laser, Ent Microsurgical Carbon-Dioxide
Regulation
21 CFR 874.4500
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Xanar, Inc. 2868 Janitell Rd., Colorado Springs CO
Third party review
No

Clearances, product code EWG

Trailing 12 months

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

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