# K973847: AL-47 Toric (Isofilcon) Soft (Toric) Daily Wear Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Martin Dalsing
- Decided: Dec 8, 1997 after 61 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 P820078 (1984). 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)
- P820078: AL-47 Soft Contact Lens, Alden Optical Labs., Inc. (1984) Summary page 3.
- (no number) Optima Toric: named in the summary without a submission number
- (no number) Soft 38 Toric: named in the summary without a submission number

## Indications for use
The AL-47 Toric (isofilcon) Soft Contact Lens 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 possesses refractive astigmatism not exceeding 10 Diopters.

Source page: https://510kreport.com/device/K973847
Methodology: https://510kreport.com/methodology