510(k) Report

Devices descending from K033398

10 later devices reach Laryngeal Augmentation Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071663VF Gel PlusCoapt Systems, Inc.20084—
+1K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc.200661
+2K081816Vocalis and Vocalis SMCytophil, Inc.20090—
+2K081815Vocalis GelCytophil, Inc.20090—
+2K080956Modification to VF Gel PlusCoapt Systems, Inc.20083—
+2K070090Radiesse Laryngeal ImplantBioform Medical, Inc.20075—
+3K180631Silk VoiceSofregen Medical, Inc.20181—
+3K121795Calcium Hydroxylapatite Vocal Fold ImplantCytophil, Inc.20130—
+3K083783VF LiquigelCoapt Systems, Inc.20090—
+4K240919Silk Voice (SMI-04)Sofregen Medical20240—