# K971647: LL BI-Focal, Daily Wear Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Lombart Lenses, Ltd.
- Decided: Jul 15, 1997 after 71 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K110452: Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens 38, Unisoft, Simulvue 38 Llbi 2, (2011), 0 descendants of its own

## Indications for use
LL Bi-Focal Soft (hydrophilic) Contact Lenses are indicated for daily wear by presbyopic patients with non-diseased eyes who are not aphakic and who have no more than 2.00 diopters of astigmatism and require powers from -6.00 to +6.00 and add powers of +1.50, +2.00, +2.50 or +3.00.

Source page: https://510kreport.com/device/K971647
Methodology: https://510kreport.com/methodology