Cleared Special

RADIESSE LARYNGEAL IMPLANT (K070090) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K070090 · Bioform Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
50d
Days
Class 2
Risk

K070090 is an FDA 510(k) clearance for the RADIESSE LARYNGEAL IMPLANT. Classified as System, Vocal Cord Medialization (product code MIX), Class II - Special Controls.

Submitted by Bioform Medical, Inc. (San Mateo, US). The FDA issued a Cleared decision on March 1, 2007 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bioform Medical, Inc. devices

Submission Details

510(k) Number K070090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2007
Decision Date March 01, 2007
Days to Decision 50 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 89d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MIX System, Vocal Cord Medialization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - MIX System, Vocal Cord Medialization

All 16
Devices cleared under the same product code (MIX) and FDA review panel - the closest regulatory comparables to K070090.
Silk Voice (SMI-04)
K240919 · Sofregen Medical · May 2024
Silk Voice
K180631 · Sofregen Medical, Inc. · Nov 2018
LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
K011554 · Biomet, Inc. · Jun 2001
VOCOM SILICONE SYSTEM
K001466 · Smith & Nephew, Inc. · Jul 2000
VOCOM IMPLANT- 8MM
K000533 · Smith & Nephew, Inc. · Mar 2000