# K973967: AL-47 (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Tinted, Lathe-Cut From Lens Blank)

- Pathway: 510(k) (Traditional)
- Applicant: Alden Optical Labs., Inc.
- Decided: Dec 8, 1997 after 52 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
Longest line of descent: 1 generation back to K961103 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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) Co Soft 38 Toric: named in the summary without a submission number
- (no number) Metrolite: named in the summary without a submission number
- (no number) AL-47 (polymacon) Series: named in the summary without a submission number

## Recalls of this device
- Nov 3, 2017 · Class II · Z-0983-2018: Contact lenses lack sterility assurance.

## Indications for use
The ALDEN CLASSIC (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 astigimatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The ALDEN CLASSIC (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 astigrnatism not exceeding 10 Diopters.

Source page: https://510kreport.com/device/K973967
Methodology: https://510kreport.com/methodology