# K071823: Perma Facial Implants

- Pathway: 510(k) (Traditional)
- Applicant: Surgisil
- Decided: Sep 19, 2007 after 78 days
- Product code: ODU (Facial Implant)
- Device class: 2
- Regulation: 21 CFR 878.3500
- 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 K983041 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982688: Spectrum Designs Pre-Form Contour Silicone Carving Block, Spectrum Designs, Inc. (1998) Summary page 1.
- K021820: Aart Silicone Carving Block, Aesthetic and Reconstructive Technologies, Inc. (2002) Summary page 1.
- K983041: Seare Biomedical Silicone Sheeting, Seare Biomedical Corp. (1998) Summary page 1.
- K022223: Aart Silicone Sheeting, Aesthetic and Reconstructive Technologies, Inc. (2002) Summary page 1.

## Indications for use
The Perma Facial Implants are solid silicone implants that are intended for use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections in the face, including areas such as the nose, chin, and cheeks.

Source page: https://510kreport.com/device/K071823
Methodology: https://510kreport.com/methodology