Art Optical Contact Lens, Inc. is one of 16294 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Art Optical Contact Lens, Inc. - FDA 510(k) Cleared Devices
Recent clearances: IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A), Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D), Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)
6
Total
6
Cleared
0
Denied
Art Optical Contact Lens, Inc. has 6 FDA 510(k) cleared medical devices. Based in Grand Junction, US.
Last cleared in 2023. Active since 2008. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Art Optical Contact Lens, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Eyereg Consulting, Inc. as regulatory consultant. 2 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Art Optical Contact Lens, Inc.
6 devices
Cleared
Sep 06, 2023
IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
Ophthalmic
166d
Cleared
Sep 20, 2017
Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
Ophthalmic
50d
Cleared
CT
Nov 24, 2015
Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens...
Ophthalmic
124d
Cleared
CT
Jan 12, 2015
Intelliwave4
Ophthalmic
117d
Cleared
Sep 14, 2010
INTELLIWAVE3
Ophthalmic
231d
Cleared
Jul 03, 2008
INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR...
Ophthalmic
190d