# K162005: Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Acuity Polymers, Inc.
- Decided: Dec 8, 2016 after 141 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: 5 generations back to K943177 (1994). 8 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071043: Boston XO (Hexafocon a), Boston EO (Enflufocon B)  and Boston ES (Enflufocon a) Rigid Gas Permeable Contact Lenses, Bausch & Lomb, Inc. (2007) Summary page 4.

## Most influential descendants
- K201194: Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (2020), 7 descendants of its own
- K203571: Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (2021), 6 descendants of its own
- K233325: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) (2024), 4 descendants of its own
- K230965: Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens (2023), 4 descendants of its own
- K213538: Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (2021), 4 descendants of its own

## Indications for use
The Acuity 100™ (hexafocon A) 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/K162005
Methodology: https://510kreport.com/methodology