# K013220: HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully Cast-Molded Lens)

- Pathway: 510(k) (Traditional)
- Applicant: Poly Vue Technolgies, Inc.
- Decided: Nov 20, 2001 after 55 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: 2 generations back to K953807 (1996). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982110: Polyvue 43 (Ocufilcon a) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lenses for Daily Wear, Optech, Inc. (1998) Summary page 2.
- K980818: Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical, Aspherical, Toric and Multifocal Hydrophilic Contact Lense), Stephen A. Dunn, Inc. (1998) Summary page 2.
- P780007: Hydron Hydrophilic Contact Lens, CooperVision, Inc. (1979) Summary page 2.

## Most influential descendants
- K020608: HD/HDT, (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully Cast-Molded Lens) (2002), 2 descendants of its own
- K221517: POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens (2022), 1 descendant of its own
- K242855: P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (2025), 0 descendants of its own
- K142766: I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear (2015), 0 descendants of its own

## Indications for use
The HD (polymacon) Aspheric 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 1.50 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 HDT (polymacon) Aspheric Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in 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. The PV (polymacon) Multi-Aspheric Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 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 PVT (polymacon) Multi-Aspheric Toric Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia, possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic. 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/K013220
Methodology: https://510kreport.com/methodology