510(k) Report

Devices descending from K060815

6 later devices reach Juliesse Injectable Laryngeal Augmentation Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070090Radiesse Laryngeal ImplantBioform Medical, Inc.20075—
+2K180631Silk VoiceSofregen Medical, Inc.20181—
+2K121795Calcium Hydroxylapatite Vocal Fold ImplantCytophil, Inc.20130—
+2K081816Vocalis and Vocalis SMCytophil, Inc.20090—
+2K081815Vocalis GelCytophil, Inc.20090—
+3K240919Silk Voice (SMI-04)Sofregen Medical20240—