Art Optical Contact Lens, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Art Optical Contact Lens, Inc.” (first 2008, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 145 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 2 | 120 |
| 2016 | 0 | — |
| 2017 | 1 | 50 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 166 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Art Optical Contact Lens, Inc. took a median 108 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 5 | 5 |
| HQD | Lens, Contact (Other Material) - Daily | 1 | 1 |
Review panels
- Ophthalmic (6)
Most recent Art Optical Contact Lens, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230824 | IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) | LPL | 2023-09-06 | 166 |
| K172314 | Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) | HQD | 2017-09-20 | 50 |
| K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) | LPL | 2015-11-24 | 124 |
| K142641 | Intelliwave4 | LPL | 2015-01-12 | 117 |
| K100221 | INTELLIWAVE3 | LPL | 2010-09-14 | 231 |
| K073621 | INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT | LPL | 2008-07-03 | 190 |
Recalls
openFDA lists no recalls under a recalling firm named Art Optical Contact Lens, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Art Optical Contact Lens, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05559567: Axial Length With Adult Onset Myopia (ALWAOM) (Enrolling by invitation, started 2023-09-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Art Optical Contact Lens, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Art Optical Contact Lens, Inc.” (first 2008, latest 2023), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Art Optical Contact Lens, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Art Optical Contact Lens, Inc. is 145 days.
Which FDA product codes appear under Art Optical Contact Lens, Inc.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 5); HQD (Lens, Contact (Other Material) - Daily, 1).
Next steps
- See all 6 Art Optical Contact Lens, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Art Optical Contact Lens, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.