Art Optical Contact Lens, Inc.
Art Optical Contact Lens, Inc. appears in FDA public data with 0 recalls, 6 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Aug 30, 2017 (Voluntary Action Indicated (VAI)). Its most recent 510(k) clearance was granted on Sep 6, 2023.
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Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 3
- Compliance Actions
- 0
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 30, 2017 | Walker, MI | Devices | Voluntary Action Indicated (VAI) | 3002340631 |
| Dec 12, 2011 | Walker, MI | Devices | No Action Indicated (NAI) | 3002340631 |
| Dec 31, 2009 | Walker, MI | Devices | No Action Indicated (NAI) | 3002340631 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K230824 | IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) | Sep 6, 2023 |
| K172314 | Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) | Sep 20, 2017 |
| K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) | Nov 24, 2015 |
| K142641 | Intelliwave4 | Jan 12, 2015 |
| K100221 | INTELLIWAVE3 | Sep 14, 2010 |
| K073621 | INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY… | Jul 3, 2008 |