# K081815: Vocalis Gel

- Pathway: 510(k) (Traditional)
- Applicant: Cytophil, Inc.
- Decided: Jan 5, 2009 after 193 days
- Product code: MIX (System, Vocal Cord Medialization)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913882 (1992). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080956: Modification to VF Gel Plus, Coapt Systems, Inc. (2008) Summary page 2.
- K013243: Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1, Bioform, Inc. (2002) Summary page 2.
- K070090: Radiesse Laryngeal Implant, Bioform Medical, Inc. (2007) Summary page 2.
- K071663: VF Gel Plus, Coapt Systems, Inc. (2008) Summary page 2.

## Indications for use
Vocalis Gel is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Vocalis Gel injection augments the size .of the displaced or deformed vocal fold so that it may meet, the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication. The product is intended to be durable for a minimum of one·month.

Source page: https://510kreport.com/device/K081815
Methodology: https://510kreport.com/methodology