Unicon Optical Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™, Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens, UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Unicon Optical Co., Ltd. Ophthalmic ✕
5 devices
Cleared
Jul 12, 2024
OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™
Ophthalmic
29d
Cleared
Jan 18, 2022
Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
Ophthalmic
111d
Cleared
Sep 17, 2019
UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
Ophthalmic
60d
Cleared
May 16, 2019
Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily...
Ophthalmic
230d
Cleared
Oct 17, 2014
UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR...
Ophthalmic
94d