# K013649: Sauflon 55 UV Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Sauflon Pharmaceuticals, Ltd.
- Decided: Dec 26, 2001 after 51 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: 3 generations back to K951893 (1995). 4 ancestors in all.
7 later devices descend from it; 3 cite 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)
- K973063: Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear, Aspect Vision Care, Ltd. (1997) Summary page 1.

## Most influential descendants
- K020392: Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily Wear (2002), 3 descendants of its own
- K182247: ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) (2018), 2 descendants of its own
- K133735: Eye Secret 55 UV Aspheric (Methafilcon a) Soft (Hydrophilic) Contact Lens (2014), 1 descendant of its own
- K243953: Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) (2025), 0 descendants of its own
- K192225: Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses (2019), 0 descendants of its own

## Indications for use
The Sauflon 55 UV soft (hydrophilic) contact lens is indicated for daily wear for the correction of the refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dioptres that does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

Source page: https://510kreport.com/device/K013649
Methodology: https://510kreport.com/methodology