# K170658: Lympha Press Optimal Plus

- Pathway: 510(k) (Traditional)
- Applicant: Mego Afek AC, Ltd.
- Decided: May 31, 2017 after 89 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as: • Primary lymphedema • Secondary lymphedema • Venous insufficiency • Venous stasis ulcers • Dysfunction of the muscle pump • Post mastectomy edema • Edema following trauma and sports issues • Post immobilization edema • Reduction of wound healing time • Reduction of pain and swelling after injury and surgery • The device may also be beneficial in the management of Lipoedema The device is intended for hospital, home, and clinic use.

Source page: https://510kreport.com/device/K170658
Methodology: https://510kreport.com/methodology