510(k) Report

Devices descending from K013243

11 later devices reach Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081816Vocalis and Vocalis SMCytophil, Inc.20090—
+1K081815Vocalis GelCytophil, Inc.20090—
+1K070090Radiesse Laryngeal ImplantBioform Medical, Inc.20075—
+1K033398Laryngeal Augmentation ImplantBioform, Inc.200310—
+2K180631Silk VoiceSofregen Medical, Inc.20181—
+2K121795Calcium Hydroxylapatite Vocal Fold ImplantCytophil, Inc.20130—
+2K071663VF Gel PlusCoapt Systems, Inc.20084—
+2K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc.200661
+3K240919Silk Voice (SMI-04)Sofregen Medical20240—
+3K080956Modification to VF Gel PlusCoapt Systems, Inc.20083—
+4K083783VF LiquigelCoapt Systems, Inc.20090—