# K233999: GalaFLEX LITE Scaffold

- Pathway: 510(k) (Traditional)
- Applicant: Tepha, Inc.
- Decided: Apr 9, 2024 after 113 days
- Product code: OOD (Surgical Film)
- Device class: 2
- Regulation: 21 CFR 878.3300
- 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 K113721 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113721: Tephaflex Light Mesh, Tepha, Inc. (2012) Summary page 5.

## Indications for use
GalaFLEX LITE Scaffold is intended to reinforce soft tissue, where weakness exists, in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Source page: https://510kreport.com/device/K233999
Methodology: https://510kreport.com/methodology