# K090806: Safi-Gel Daily Disposable (Methafilcon a) Soft (Hydrophilic) Contact Lens, Safi-Gel Daily Disposable Toric ( Methafilcon

- Pathway: 510(k) (Traditional)
- Applicant: Safilens, S.R.L.
- Decided: Dec 18, 2009 after 268 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 K051095 (2005). 1 ancestor in all.
12 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051095: 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear, Optical Connection, Inc. (2005) Summary page 1.

## Most influential descendants
- K121201: Savie-Aqua 55UV (Methafilcon a) Tinnted Blue Soft (Hydrophilic) Contact Lens (2012), 11 descendants of its own
- K162317: Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens (2016), 7 descendants of its own
- K200296: Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses (2020), 4 descendants of its own
- K211448: Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses (2021), 2 descendants of its own
- K132146: Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 58 UV Toric (Etafilcon a) (2013), 2 descendants of its own

## Indications for use
The Safi-gel Daily Disposable (mnethafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or comeal astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Safi-gel Daily Disposable Multifoical (metharilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Safi-gel Daily Disposable Toric (metharilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non diseased eyes. The Safi-gel Daily Disposable Lenses are to be prescribed for single-use disposable wear, and are to be discarded after each removal.

Source page: https://510kreport.com/device/K090806
Methodology: https://510kreport.com/methodology