# K971515: Promed 38 Sofblu (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Tinted, Lathe-Cut Form Lens Blank)

- Pathway: 510(k) (Traditional)
- Applicant: Biomed Devices Corp.
- Decided: May 20, 1997 after 25 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The PROMED 38 SOFBLU (Toric) (polymacon) SOFT CONTACT LENSES for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and refractive astigmatism not exceeding 10 Diopters. The PROMED 38 SOFBLU (Spherical) (polymacon) SOFT CONTACT LENSES for daily wear are indicated for the correction of visual acuity in aphakic and pot aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

Source page: https://510kreport.com/device/K971515
Methodology: https://510kreport.com/methodology