510(k) Report

FDA applicant

Bioform Medical, Inc.

San Mateo, CA3 decisions2006–20081 recall

FDA records 3 decisions for Bioform Medical, Inc. (San Mateo, CA) from 2006 to 2008: 3 510(k) clearances. Most are in product codes MIX (System, Vocal Cord Medialization) and GXD (Generator, Lesion, Radiofrequency). Its devices cite 5 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Bioform Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bioform Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bioform Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MIXSystem, Vocal Cord Medialization2decisions
  • GXDGenerator, Lesion, Radiofrequency1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070090Radiesse Laryngeal ImplantBioform Medical, Inc. · 20074cite it
  • K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 20061cites it

What has FDA decided for it lately?

  • K081729Modification to GFX Nerve Ablation SystemBioform Medical, Inc. · 2008
  • K070090Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007
  • K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 20061 recall

All 3 as Bioform Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K060815PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant…Oct 26, 2015Class II

Other applicant names beginning “Bioform”

FDA records each applicant name separately; these may or may not be the same firm.

Bioform, Inc. 4