510(k) K060815
- Device
- JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT
- Applicant
- BIOFORM MEDICAL, INC.
- 510(k) number
- K060815
- Product code
- MIX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-04-18
- Date received
- 2006-03-27
- 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
- JAMES S MILLER
- Address
- 1875 S. Grant St.,Suite 11o San Mateo CA US 94402 94402
FDA Registration Numbers#
- 3007225376
- 1450662
- 1219795
- 3011050570
- 3003790304
- 1037007
- 1928237
- 3013840437
- 3002647932
- 2135225
Source Documents#
Other 510(k) Records For Product Code MIX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240919 | Silk Voice (SMI-04) | Sofregen Medical | 2024-05-03 |
| K180631 | Silk Voice | Sofregen Medical, Inc. | 2018-11-08 |
| K150400 | Renu Gel | Cytophil, Inc. | 2015-04-06 |
| K121795 | CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT | Cytophil, Inc. | 2013-02-22 |
| K083783 | VF LIQUIGEL | Coapt Systems, Inc. | 2009-09-11 |
| K081815 | VOCALIS GEL | Cytophil, Inc. | 2009-01-05 |
| K081816 | VOCALIS AND VOCALIS SM | Cytophil, Inc. | 2009-01-05 |
| K080956 | MODIFICATION TO VF GEL PLUS | Coapt Systems, Inc. | 2008-04-25 |
| K071663 | VF GEL PLUS | Coapt Systems, Inc. | 2008-02-15 |
| K070090 | RADIESSE LARYNGEAL IMPLANT | Bioform Medical, Inc. | 2007-03-01 |
| K033398 | LARYNGEAL AUGMENTATION IMPLANT | Bioform, Inc. | 2003-12-12 |
| K011554 | LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT | Biomet, Inc. | 2001-06-26 |
| K001466 | VOCOM SILICONE SYSTEM | Smith & Nephew, Inc. | 2000-07-26 |
| K000533 | VOCOM IMPLANT- 8MM | Smith & Nephew, Inc. | 2000-03-01 |
| K983525 | GORE REVOX THYROPLASTY IMPLANT | W. L. Gore & Associates, Inc. | 1998-12-10 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases