510(k) Report

Devices descending from K043012

5 later devices reach Omnipulse Mini, Model 2120 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061455Dornier Medilas H 20 LaserDornier Medtech America, Inc.20064—
+2K130344Dornier Medilas UropulseDornier Medtech America, Inc.20130—
+2K122159Dornier Medilas H30 SolvoDornier Medtech America, Inc.20132—
+2K080525Cook Odyssey Holmium Laser System, Model 30WCook Urological, Inc.20080—
+3K180350Dornier Medilas H Solvo 35 LaserDornier Medtech America20180—