# K170007: Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Acuity Polymers, Inc.
- Decided: May 31, 2017 after 148 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
Longest line of descent: 2 generations back to K943177 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980741: Boston EO Rigid Gas Permeable Contact Lens Material (Enflofocon B), Polymer Technology Div. Wilmington Partners, L.P. (1998) Summary page 4.

## Indications for use
The Acuity 58™ (en:flufocon B) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical and aspheric powers ranging from -20.00 D to +20.00 D for daily wear. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K170007
Methodology: https://510kreport.com/methodology