Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K827914Substantially Equivalent

Niic CO2 Laser System Model 3Oz.

Cooper Lasersonics, Inc., Orangeburg NY / Traditional, Substantially Equivalent

K827914 is the FDA 510(k) clearance record for NIIC CO2 LASER SYSTEM MODEL 3OZ., cleared for Cooper Lasersonics, Inc. on . FDA records list 54 510(k) clearances for Cooper Lasersonics, Inc., from to . As of , FDA records show no recalls naming K827914.

Clearance record

Decision date
Received
(31 days to decision)
Review panel
Unknown
Applicant
Cooper Lasersonics, Inc. 40 Ramland Rd., Orangeburg NY
Third party review
No