The following data is part of a premarket notification filed by Art Optical Contact Lens, Inc. with the FDA for Intelliwave4.
| Device ID | K142641 |
| 510k Number | K142641 |
| Device Name: | Intelliwave4 |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ART OPTICAL CONTACT LENS, INC. 3175 3 MILE ROAD Walker, MI 49534 |
| Contact | Michael Johnson |
| Correspondent | Bret Andre EyeReg Consulting, Inc. 474 NE 61st PL Hillsboro, OR 97124 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-17 |
| Decision Date | 2015-01-12 |
| Summary: | summary |