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Acuity 18

by Acuity Polymers Inc.

Acuity 18 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 28 Sep 2017 (UDI-DI 00850203008019), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K163254

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850203008019 UDI-DI Date28 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK163254 Date18 Jan 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K163254 decided 18 Jan 2017 Active
  • FDA GUDID UDI-DI 00850203008019 listed 28 Sep 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K163254
  2. Listed FDA GUDID 00850203008019

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Acuity
Generic name
Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
Model / reference
18
Description
Rigid-gas-permeable contact lens - daily wear enflufocon A
Primary DI / UDI-DI
00850203008019
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

Related devices

Category: Rigid-gas-permeable corrective contact lens, daily-wear

Cleared under the same submission (K163254)

Similar devices

Other devices filed under FDA product code HQD (Lens, Contact (Other Material) - Daily).

Other devices from Acuity Polymers Inc.

  • Acuity 85

    Class II

  • Acuity 181

    Class II

  • Acuity 100

    Class II

  • Acuity 58

    Class II

See all devices from Acuity Polymers Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)