Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
FDA 510(k) clearance K180988 · decided 2018-06-08
Clearance details
- K-number
- K180988
- Device name
- Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
- Applicant
- Acuity Polymers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-04-16
- Decision date
- 2018-06-08
- Days to decision
- 53 days
- Clearance type
- Abbreviated
- Product code
- HQD
- Device class
- 2
- Regulation number
- 886.5916
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| GPA (hexafocon A) Rigid Gas Permeable Contact Lenses (K253822) | Zhuhai Fitlens Medical Technology Co., Ltd. | 2026-03-27 |
| Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses (K242393) | Acuity Polymers, Inc. | 2024-11-01 |
| SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses (K241398) | Tianjin Mastervision Technology Co., Ltd. | 2024-10-22 |
| BostonSight® Specialty Lenses (K241571) | Boston Foundation For Sight, Inc. D/B/A Bostonsight | 2024-08-14 |
| 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 (K240618) | Acuity Polymers, Inc. | 2024-04-03 |
| Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) (K233325) | Visionary Optics, LLC | 2024-02-21 |
| NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens (K230910) | Acculens, Inc. | 2023-06-16 |
| Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens (K230965) | Acuity Polymers, Inc. | 2023-06-16 |
| Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses (K221768) | Paragon Vision Sciences, Inc. | 2023-05-05 |
| Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) (K223394) | Visionary Optics, LLC | 2022-12-07 |
| Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses (K212631) | Contamac, Ltd. | 2022-03-17 |
| Custom Stable Rigid Gas Permeable Scleral Contact Lens (K213880) | Valley Contax, Inc. | 2022-01-07 |
Recalls involving this device
No recalls on record reference this clearance.