# K240618: Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens

- Pathway: 510(k) (Special)
- Applicant: Acuity Polymers, Inc.
- Decided: Apr 3, 2024 after 29 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: 12 generations back to K943177 (1994). 59 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233325: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A), Visionary Optics, LLC (2024) Summary page 6.
- K201194: Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, Acuity Polymers, Inc. (2020) Summary page 6.
- K162005: Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens, Acuity Polymers, Inc. (2016) Summary page 6.
- K213538: Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, Acuity Polymers, Inc. (2021) Summary page 6.
- K230965: Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens, Acuity Polymers, Inc. (2023) Summary page 6.
- K180616: OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens, Contamac, Ltd. (2018) Summary page 6.

## Most influential descendants
- K242393: Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses (2024), 0 descendants of its own
- K241398: SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses (2024), 0 descendants of its own
- K241571: BostonSight® Specialty Lenses (2024), 0 descendants of its own

## Indications for use
The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (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 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 Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren’s syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the lens may concurrently provide correction of refractive error. The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.

Source page: https://510kreport.com/device/K240618
Methodology: https://510kreport.com/methodology