# K983053: Alden Classic Prosthetic (Polymacon) Tinted, Soft Daily Wear Contact Lens (Sighted and Non-Sighted Eyes)

- Pathway: 510(k) (Traditional)
- Applicant: Alden Optical Labs., Inc.
- Decided: Oct 21, 1998 after 50 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) WESLEY-JESSEN PROSTHETIC (phemfilcon A) Soft Contact Lens: named in the summary without a submission number
- (no number) BENZ 38 (polymacon) Soft Contact Lens: named in the summary without a submission number

## Most influential descendants
- 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 PROSTHETIC (polymacon) Tiated, Soft Contact Lens (Lathe-cut) is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact Jenses for cosmetic management of conditions such as comeal, inis or lens abnormalities, The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in apbakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. Thelens may be disinfected with either a chemical or 8 heat disinfection system.

Source page: https://510kreport.com/device/K983053
Methodology: https://510kreport.com/methodology