# K013732: Gelzone

- Pathway: 510(k) (Traditional)
- Applicant: Implantech Associates, Inc.
- Decided: Feb 7, 2002 after 90 days
- Product code: MDA (Elastomer, Silicone, For Scar Management)
- Device class: 1
- Regulation: 21 CFR 878.4025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964846 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964846: Implatech RP Medical Grade Silicone Gel Sheeting, Implantech Associates, Inc. (1997) Summary page 1.
- K012419: Conform Sheeting, Model Igel, Implantech Associates, Inc. (2001) Summary page 1.
- K972597: PMT New Beginnings Gelshapes & Amend, Pmt Corp. (1997) Summary page 1.

## Indications for use
Gelzone is indicated for use in the management of keloid and hypertrophic scars. Gelzone may also be used prophylactically to help retard the formation of such scars.

Source page: https://510kreport.com/device/K013732
Methodology: https://510kreport.com/methodology