# K964696: Sunsoft (Methafilcon a) Soft (Hydrophilic) Daily Wear Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Sunsoft Corp.
- Decided: Feb 20, 1997 after 90 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 1 (0 Class I)
- 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. The FDA summary names its predicate without a number.
- (no number) Sunsoft (methafilcon A) Soft (Hydrophilic) Contact Lens: named in the summary without a submission number

## Recalls of this device
- Dec 9, 2004 · Not classified · Z-0348-05: Vials containing the lenses are possibly contaminated with residual hydrogen peroxide.

## Indications for use
It is indicated for the correction of visual acuity.

Source page: https://510kreport.com/device/K964696
Methodology: https://510kreport.com/methodology