# K961606: Metro Focal Aspheric (Polymacon)

- Pathway: 510(k) (Traditional)
- Applicant: Metro Optics of Austin, Inc.
- Decided: Nov 20, 1996 after 209 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The METRO FOCAL 38 ASPHERIC (polymacon) soft (hydrophilic) contact lenses for daily wear are available in clear and with a blue visibility tint. The lenses are indicated for visual acuity in non-aphakic patients with with non-diseased eyes. The lenses are available in powers of -20.00 up to +10.00 Diopters of and up to 2.50 Diopters of add. These lenses will mask 2.00 Diopters of astigmatism where it does not interfere with visual acuity.

Source page: https://510kreport.com/device/K961606
Methodology: https://510kreport.com/methodology