Acuity 181
Acuity 181 is a Class II device made by Acuity Polymers Inc., cleared under FDA 510(k) K163254 on 18 Jan 2017 and listed in FDA GUDID since 9 Jun 2025 (UDI-DI 00850203008330), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850203008330 | Date9 Jun 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163254 | Date18 Jan 2017 | StatusActive |
Official records
- AccessGUDID record 00850203008330
- FDA 510(k) database K163254
Across registries
- FDA 510(k) K163254 decided 18 Jan 2017 Active
- FDA GUDID UDI-DI 00850203008330 listed 9 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K163254
- Listed FDA GUDID 00850203008330
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Acuity
- Generic name
- Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
- Model / reference
- 181
- Description
- Rigid-gas-permeable contact lens - daily wear tisilfocon A
- Primary DI / UDI-DI
- 00850203008330
- 510(k) Number
- FDA product code
- HQD
- GMDN term
- Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
- Device class
- Class II
- Regulation number
- 886.5916
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Liquid Chemical
- MRI safety
- MR Safe
Similar devices
Other devices filed under FDA product code HQD (Lens, Contact (Other Material) - Daily).
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- BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL by BENZ RESEARCH AND DEVELOPMENT LLC
- Trans Aire Rigid Gas Permeable Contact Lens by Rand Scientific Corp.
- BOSTON VII by Polymer Technology Corp.
- Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens by Bausch & Lomb Incorporated
- O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS by Optical Polymer Research, Inc.