# K131496: Bellavar / Custom Seamless Soft (a.K.a. Comtesse)

- Pathway: 510(k) (Special)
- Applicant: Bsn Medical, Inc.
- Decided: Jul 10, 2013 after 48 days
- Product code: DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs))
- Device class: 2
- Regulation: 21 CFR 880.5780
- 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
Compression Class I Mild swelling, tired aching legs, thrombosis prophylaxis, minor varices, post surgery Compression Class II Primary varices, varices with edema, varices with pregnancy; post-scierotherapy; post venous ulceration Compression class III Secondary varices; severe varices wich edema; post-phiebitic syndrome; chronic venous insufficiency; phlebitis; thrombophlebitis and edema

Source page: https://510kreport.com/device/K131496
Methodology: https://510kreport.com/methodology