# K970746: SEE3 (Lotrafilcon a) Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Vision Corporation
- Decided: May 9, 1997 after 70 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 P810005 (1981). 2 ancestors in all.
96 later devices descend from it; 4 cite it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P810005: Weicon (R) (Tefilicon) Hydrophilic Contact Lens, Ciba Vision Care (1981) Summary page 1.
- P820086: Cibatint (TM) Tinting Process, Ciba Vision Care (1984) Summary page 1.

## Most influential descendants
- K020139: Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design (2002), 95 descendants of its own
- K033919: Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs (2004), 94 descendants of its own
- K052560: Biofinity (Comfilcon a) Soft Contact Lens (2005), 74 descendants of its own
- K100221: INTELLIWAVE3 (2010), 32 descendants of its own
- K073459: Ciba Vision (Lotrafilcon B) Soft Contact Lenses (2008), 17 descendants of its own

## Indications for use
SEE3™ (lotrafilcon A) soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear with removal for cleaning and disinfection and monthly replacement. SEE3™ (lotrafilcon A) lenses may be cleaned using a chemical, not heat, disinfection system.

Source page: https://510kreport.com/device/K970746
Methodology: https://510kreport.com/methodology