# K983021: Metrosoft II, Metrosoft Toric, Metrolite, Metrotint, Satureyes, Satureyes Toric, Satureyes Lite, Satureyes Lite Toric

- Pathway: 510(k) (Traditional)
- Applicant: Metrosoft, Inc.
- Decided: Nov 13, 1998 after 74 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- 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
MetroSoft 1II, MetroTint and MetroLite contact lens are indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes who may have 1.50 diopters or less of astigmatism that does not interfere with visual acuity. The lens power range is -20.00 diopters to +20.00 diopters. MetroSoft Toric contact lens for daily wear are indicated for use by patients with non-diseased eyes who are not aphakic or aphakic and who have refractive and/or comeal astigmatism of up to 6.00 diopters and require powers from -20.00 to +20.00 diopters. SaturEyes spherical (hioxyfilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of visual acuity in non aphakic persons with non-diseased eyes with myopia or hyperopia and astigmatism of up to 1.5 Diopters where the astigmatism does not interfere with visual acuity. SaturEyes Toric (hioxyfilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of visual acuity in non aphakic persons with non-diseased eyes with myopia or hyperopia and corneal astigmatism of up to 4.00 Diopters or less where the astigmatism does not interfere with visual acuity.

Source page: https://510kreport.com/device/K983021
Methodology: https://510kreport.com/methodology