# K964902: Contact Lenses Metro-G 3X (Hioxifilcon B)

- Pathway: 510(k) (Traditional)
- Applicant: Metro Optics of Austin, Inc.
- Decided: Mar 11, 1997 after 95 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.
12 later devices descend from it; 3 cite it directly.
0 of 13 devices 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) METRO-G 55 (5X) (hioxifilcon A): named in the summary without a submission number

## Most influential descendants
- K080512: Revitaleyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) Clear and Blue Visibility Tint (2008), 9 descendants of its own
- K100244: Metro Soft (2010), 8 descendants of its own
- K123120: Lensx Laser System (2012), 5 descendants of its own
- K161288: LenSX Laser System (2016), 4 descendants of its own
- K163551: LenSx Laser System (2017), 3 descendants of its own

## Indications for use
METRO-G 3X Spherical (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or a blue visibility tint are indicated in daily wear for the correction of visual acuity in aphapic and/or non-aphakic persons with with non-diseased eves. The Spherical lenses are available from +20.00 to - 20.00 Diopters for persons with up to1.50 Diopters of astigmatism where the astigmatism does not interfere with visual acuity. METRO-G 3X Toric (hioxifilcon B) soft (hvdrophilicl contact lenses made from RENZETRO-G 3X (hioxifilcon B) optical blanks in alear or blue visibility tint sre indicated in daily wear for the correction of visual acuity in aphakic and non-aphakic persons with with non-diseased eyes. The toric lenses are avaijlable from +20.00 to ~20.00 Diopters and up to 4_50 Diopters nf astigmatic correction.

Source page: https://510kreport.com/device/K964902
Methodology: https://510kreport.com/methodology