# K123973: Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Pegavision Corporation
- Decided: Apr 23, 2013 after 118 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 K950283 (1995). 7 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K020927: Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens, Bausch & Lomb (2002) Summary page 2.
- K042824: Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact Lens, CooperVision, Inc. (2004) Summary page 2.

## Most influential descendants
- K132714: Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and Cosmetic Tinted) (2014), 1 descendant of its own
- K142384: DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) (2014), 0 descendants of its own

## Indications for use
Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lenses and Aquamax (polymacon) Monthly Disposable Soft (hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D)or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00 D to -20.00 D. Eye practitioners may prescribe the lens for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only. Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Source page: https://510kreport.com/device/K123973
Methodology: https://510kreport.com/methodology