JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT— 510(k) K060815

Name: FDA 510(k) clearance K060815
Creator: U.S. Food and Drug Administration
Published: 2006-04-18

Substantially Equivalent

Bioform Medical, Inc.

FDA 510(k) clearance K060815 for JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT, Substantially Equivalent on 2006-04-18. Applicant: Bioform Medical, Inc.. Device class: 2.

Clearance details

Applicant: Bioform Medical, Inc.
Product code: Code MIX
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2006-03-27
Decision date: 2006-04-18
Decision: Substantially Equivalent
Clearance type: Special
Location: San Mateo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MIX

view all

K240919 — Silk Voice (SMI-04)2024-05-03
K180631 — Silk Voice2018-11-08
K150400 — Renu Gel2015-04-06
K121795 — CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT2013-02-22
K083783 — VF LIQUIGEL2009-09-11

More clearances from Bioform Medical, Inc.

view all

K081729 — MODIFICATION TO GFX NERVE ABLATION SYSTEM2008-08-07
K070090 — RADIESSE LARYNGEAL IMPLANT2007-03-01

Recalls naming K060815

K-number listed on FDA's recall record

Z-0367-2016 — PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.Class II·Terminated·Merz North America, Inc.·20151026

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060815.

Data sourced from openFDA. This site is unofficial and independent of the FDA.