# K111345: See Clear Soft Contact Lens, See Clear Color Soft Contact Lens, Fierce Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: The See Clear Company, Inc.
- Decided: Nov 2, 2011 after 173 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K051477 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051477: Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens for Daily Wear (Clear, Tinted and Cosmetic), Mi Gwang Contact Lens Co., Ltd. (2006) Summary page 2.

## Recalls of this device
- Jan 6, 2017 · Class II · Z-1404-2017: Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.

## Indications for use
The See Clear Spherical Soft Contact Lenses (polymnacon) for Daily Wear are indicated for the correction of visual acuity in aphakic and not aphakic person with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Source page: https://510kreport.com/device/K111345
Methodology: https://510kreport.com/methodology