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510(k) K240919

Device
Silk Voice (SMI-04)
Applicant
Sofregen Medical
510(k) number
K240919
Product code
MIX
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-03
Date received
2024-04-03
Regulation
874.3620
Classification name
System, Vocal Cord Medialization
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Vivian Ruan
Address
175 Crossing Blvd., Suite 510 Framingham MA US 01702 01702

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MIX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K180631Silk VoiceSofregen Medical, Inc.2018-11-08
K150400Renu GelCytophil, Inc.2015-04-06
K121795CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANTCytophil, Inc.2013-02-22
K083783VF LIQUIGELCoapt Systems, Inc.2009-09-11
K081815VOCALIS GELCytophil, Inc.2009-01-05
K081816VOCALIS AND VOCALIS SMCytophil, Inc.2009-01-05
K080956MODIFICATION TO VF GEL PLUSCoapt Systems, Inc.2008-04-25
K071663VF GEL PLUSCoapt Systems, Inc.2008-02-15
K070090RADIESSE LARYNGEAL IMPLANTBioform Medical, Inc.2007-03-01
K060815JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANTBioform Medical, Inc.2006-04-18
K033398LARYNGEAL AUGMENTATION IMPLANTBioform, Inc.2003-12-12
K011554LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANTBiomet, Inc.2001-06-26
K001466VOCOM SILICONE SYSTEMSmith & Nephew, Inc.2000-07-26
K000533VOCOM IMPLANT- 8MMSmith & Nephew, Inc.2000-03-01
K983525GORE REVOX THYROPLASTY IMPLANTW. L. Gore & Associates, Inc.1998-12-10