# K230510: MyEllevate

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, LLC
- Decided: Jul 6, 2023 after 132 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K014153 (2002). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091061: Implicitguide Surgical Suture System, Implicitcare, LLC (2009) Summary page 5.
- K001434: 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture, Genzyme Surgical Product (Genzyme Biosurgery) (2000) Summary page 7.
- K021019: Cottony II, Silky II Polydek & Tevdek II Polyester Suture, Genzyme Corp. (2002) Summary page 5.

## Indications for use
MyEllevate is indicated for use in soft tissue approximation and elevation of sub dermis and underlying muscle

Source page: https://510kreport.com/device/K230510
Methodology: https://510kreport.com/methodology