# K242393: Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Acuity Polymers, Inc.
- Decided: Nov 1, 2024 after 80 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: 13 generations back to K943177 (1994). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182304: Hyper GP (tisilfocon A) Daily Wear Contact Lens, Contamac, Ltd. (2018) Summary page 7.
- K223394: Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A), Visionary Optics, LLC (2022) Summary page 7.
- 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, Acuity Polymers, Inc. (2024) Summary page 7.

## Indications for use
The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® SPHERICAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® TORIC Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® MULTIFOCAL/BIFOCAL Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4.00 diopters and are presbyopic requiring add power of up to +4.00 diopters. The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® IRREGULAR CORNEA Daily Wear Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable 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 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® ORTHOKERATOLOGY contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters with eyes having astigmatism up to 1.50 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule. Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) SCLERAL lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject: 1. cannot be adequately corrected with spectacle lenses 2. requires a rigid gas permeable contact lens surface to improve vision 3. is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities. Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy). The Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisifocon A) SCLERAL lenses are indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjogren'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 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® (tisilfocon A) (tisilfocon A) SCLERAL lenses may concurrently provide correction of refractive error. Eyecare practitioners may prescribe the lenses or frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Source page: https://510kreport.com/device/K242393
Methodology: https://510kreport.com/methodology