Radiesse Laryngeal Implant

FDA 510(k) K070090 · Bioform Medical, Inc.

Substantially Equivalent

510(k) numberK070090

Submission

Device name
Radiesse Laryngeal Implant
Applicant
Bioform Medical, Inc.
San Mateo, CA, US
Received
January 10, 2007
Decision date
March 1, 2007
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MIX – System, Vocal Cord Medialization
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3620
Specialty
Ear, Nose, Throat
Implant
Yes

Other 510(k)s with product code MIX

510(k)DeviceApplicantDecision
K240919Silk Voice (SMI-04)MIX · Special Sofregen Medical05/03/2024SE
K180631Silk VoiceMIX · Traditional Sofregen Medical, Inc.11/08/2018SE
K150400Renu GelMIX · Special Cytophil, Inc.04/06/2015SE
K121795Calcium Hydroxylapatite Vocal Fold ImplantMIX · Traditional Cytophil, Inc.02/22/2013SE
K083783VF LiquigelMIX · Traditional Coapt Systems, Inc.09/11/2009SE
K081816Vocalis and Vocalis SMMIX · Traditional Cytophil, Inc.01/05/2009SE
K081815Vocalis GelMIX · Traditional Cytophil, Inc.01/05/2009SE
K080956Modification to VF Gel PlusMIX · Special Coapt Systems, Inc.04/25/2008SE
K071663VF Gel PlusMIX · Traditional Coapt Systems, Inc.02/15/2008SE
K060815Juliesse Injectable Laryngeal Augmentation ImplantMIX · Special Bioform Medical, Inc.04/18/2006SE

More from Bioform Medical, Inc.

510(k)DeviceDecision
K081729Modification to GFX Nerve Ablation SystemGXD · Special 08/07/2008SE
K060815Juliesse Injectable Laryngeal Augmentation ImplantMIX · Special 04/18/2006SE

Questions and answers

When was Radiesse Laryngeal Implant cleared by the FDA?

Radiesse Laryngeal Implant (K070090) received a 510(k) decision of Substantially Equivalent on March 1, 2007, 50 days after the submission was received.

What is the product code of K070090?

The FDA product code is MIX – System, Vocal Cord Medialization, a Class II (moderate risk) device regulated under 21 CFR 874.3620.