# K033599: Onsi -56 (Onsifocon a) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: The Lagado Corp.
- Decided: Sep 16, 2004 after 307 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- 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. The FDA summary names its predicate without a number.
- (no number) Oxycon (wilofocon A) Rigid Gas Permeable Contact Lenses: named in the summary without a submission number

## Indications for use
The ONSITm-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism. The lenses may be disinfected only by using chemical disinfection

Source page: https://510kreport.com/device/K033599
Methodology: https://510kreport.com/methodology