# K222748: ShiNeo Silicone Implant

- Pathway: 510(k) (Traditional)
- Applicant: Shineo Technology Co., Ltd.
- Decided: Dec 23, 2022 after 102 days
- Product code: MIB (Elastomer, Silicone Block)
- 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: 3 generations back to K021820 (2002). 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)
- K193392: BioSiCar Silicone Implant, Metalware Technology Corp. (2020) Summary page 5.

## Indications for use
ShiNeo Silicone Implant is intended for the augmentation or reconstruction of the nasal and/or chin contour

Source page: https://510kreport.com/device/K222748
Methodology: https://510kreport.com/methodology