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
K837216Substantially Equivalent

Model Xa-15 Laser System for Surgery

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

K837216 is the FDA 510(k) clearance record for MODEL XA-15 LASER SYSTEM FOR SURGERY, cleared for Xanar, Inc. on . FDA records list 11 510(k) clearances for Xanar, Inc., from to . As of , FDA records show no recalls naming K837216.

Clearance record

Decision date
Received
(35 days to decision)
Review panel
Unknown
Applicant
Xanar, Inc. 2868 Janitell Rd., Colorado Springs CO
Third party review
No