# K080512: Revitaleyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) Clear and Blue Visibility Tint

- Pathway: 510(k) (Traditional)
- Applicant: Metro Optics of Austin, Inc.
- Decided: Jul 23, 2008 after 149 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
Longest line of descent: 1 generation back to K961943 (1996). 2 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964902: Contact Lenses Metro-G 3X (Hioxifilcon B), Metro Optics of Austin, Inc. (1997) Summary page 2.
- K961943: Flexlens, Flexlens, Inc. (1996) Summary page 2.

## Most influential descendants
- 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
- K173660: LenSx Laser System (2018), 2 descendants of its own

## Indications for use
The RevitalEyes, Post-Surgical (Hioxifilcon B) Soft Contact Lenses for daily wear may be prescribed in other wise non-diseased eyes that require a soft contact lens for the management of surgically altered corneas following LASIK, PRK or RK surgery. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Source page: https://510kreport.com/device/K080512
Methodology: https://510kreport.com/methodology