Cleared Special

K060815 - JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT

K060815 is an FDA 510(k) clearance for JULIESSE INJECTABLE LARYNGEAL AUGMENTAT..., manufactured by Bioform Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code MIX cleared through the Special 510(k) pathway after a 22-day FDA review.

K060815 · Bioform Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
22d
Days
Class 2
Risk

K060815 is an FDA 510(k) clearance for the JULIESSE INJECTABLE LARYNGEAL AUGMENTATION 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 April 18, 2006 after a review of 22 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

FDA 510(k) Submission Details - K060815

510(k) Number K060815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2006
Decision Date April 18, 2006
Days to Decision 22 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 90d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

MIX Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (MIX) and FDA review panel - the closest regulatory comparables to K060815.
MODIFICATION TO VF GEL PLUS
K080956 · Coapt Systems, Inc. · Apr 2008
VF GEL PLUS
K071663 · Coapt Systems, Inc. · Feb 2008
RADIESSE LARYNGEAL IMPLANT
K070090 · Bioform Medical, Inc. · Mar 2007
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