# K081178: Optimum HR-1.51 (Hiflufocon a) and HR-1.53 (Hiflufocon B) Daily Wear Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Contamac, Ltd.
- Decided: Oct 9, 2008 after 167 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- 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 OPTIMUM HR-1.51 (hirafocon A) and OPTIMUM HR-1.53 (hirafocon B) Rigid Gas Permeable (RGP) Contact Lens are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K081178
Methodology: https://510kreport.com/methodology