Unicon Optical Co., Ltd. is one of 203 FDA 510(k) medical device manufacturers from Taiwan in the dataset, ranked by real submission volume.
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
Unicon Optical Co., Ltd. has 5 FDA 510(k) cleared medical devices. Based in New Taipei, TW.
Latest FDA clearance: Jul 2024. Active since 2014. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Unicon Optical Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Eyereg Consulting, Inc. and Andre Vision and Device Research.
FDA 510(k) Regulatory Record - Unicon Optical Co., Ltd.
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