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Juliesse Injectable Laryngeal Augmentation Implant

by Bioform Medical, Inc.

510(k) K060815

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK060815 Date18 Apr 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0367-2016 FDA Class II initiated 26 Oct 2015

    The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MIX
Device Class
Class II
Regulation
21 CFR Part 874.3620
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Juliesse Injectable Laryngeal Augmentation Implant is a resorbable implant material indicated for surgical reconstructions as a space-occupying material in laryngeal procedures for vocal fold medialization and augmentation. It is composed of an aqueous formulation of USP grade material and is designed to be a temporary implant that resorbs within a period of 3-6 months.

The device is sterile, non-pyrogenic, and supplied as an injectable implant material. It is classified as a System, Vocal Cord Medialization with product code MIX under Class II - Special Controls. The device received FDA 510(k) clearance with number K060815 and was determined to be substantially equivalent.

Other devices from Bioform Medical, Inc.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Juliesse Injectable Laryngeal Augmentation Implant used for?

    The Juliesse Injectable Laryngeal Augmentation Implant is a resorbable material used in surgical reconstructions as a space-occupying material in laryngeal procedures for vocal fold medialization and augmentation.

  • How long does the Juliesse implant last in the body?

    The Juliesse implant is designed to be temporary and resorbs within a period of 3-6 months after injection.

  • Is the Juliesse implant sterile and how is it supplied?

    Yes, the device is sterile and non-pyrogenic. It is supplied as an injectable implant material in an aqueous formulation of USP grade material.

  • What is the regulatory classification of the Juliesse implant?

    The device is classified as a System, Vocal Cord Medialization with product code MIX under Class II - Special Controls and received FDA 510(k) clearance with number K060815.