# K974837: Igel (R) 56 (Hefilcon C) Soft (Hydrophlic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Igel Vision Care Pte, Ltd.
- Decided: Jul 6, 1998 after 194 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Gold Medalist Toric lenses: named in the summary without a submission number

## Most influential descendants
- K984090: Speciality 55 Multifocal (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear, Speciality 55 (Methafilcon a) (1999), 1 descendant of its own
- K993580: Specialty 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear (2000), 0 descendants of its own

## Indications for use
The Igel®56 (hefilcon C) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism, for the spherical lens up to 1.50 diopters that does not interfere with visual acuity, and for the toric lens up to 7.00 diopters) in not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfecting systems only.

Source page: https://510kreport.com/device/K974837
Methodology: https://510kreport.com/methodology