# K980554: Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted (Transparent/Enhancing)

- Pathway: 510(k) (Traditional)
- Applicant: Alden Optical Labs., Inc.
- Decided: Apr 7, 1998 after 53 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 K961103 (1996). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961103: Benz 38 Clear & with Blue Visibility Tint, Benz Research and Development Corp. (1996) Summary page 3.
- (no number) MetroTint: named in the summary without a submission number

## Most influential descendants
- K983278: Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted an Non-Sighted Eyes) (1998), 3 descendants of its own
- K992950: Custom Prosthetic (Hefilcon a) Soft Lens (1999), 2 descendants of its own
- K041700: Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily Wear (2004), 0 descendants of its own
- K020690: Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact Lens (2002), 0 descendants of its own

## Indications for use
The ALDEN CLASSIC TINTED (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 wom by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The ALDEN CLASSIC TINTED (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 10 Diopters.

Source page: https://510kreport.com/device/K980554
Methodology: https://510kreport.com/methodology