# K051477: Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens for Daily Wear (Clear, Tinted and Cosmetic)

- Pathway: 510(k) (Traditional)
- Applicant: Mi Gwang Contact Lens Co., Ltd.
- Decided: Mar 10, 2006 after 280 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
No predicates in its family tree.
11 later devices descend from it; 5 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)
- None. The FDA summary names its predicate without a number.
- (no number) Advantage 38 (polymacon): named in the summary without a submission number
- (no number) ContaFlex 38 (polymacon): named in the summary without a submission number

## Most influential descendants
- K142275: Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens (2014), 5 descendants of its own
- K161098: ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) (2016), 2 descendants of its own
- K141699: Vassen Color (2014), 2 descendants of its own
- K241884: HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) (2025), 0 descendants of its own
- K220143: BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens (2022), 0 descendants of its own

## Recalls of this device
- May 10, 2006 · Not classified · Z-1257-06: Contact lenses were distributed and sold to inappropriate retail establishments without professional eye care involvement.

## Indications for use
The MiGwang Comfort 38 (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons 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. The MiGwang Comfort 38 (polymacon) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. Eyecare practitioners may prescribe any of 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/K051477
Methodology: https://510kreport.com/methodology