The following data is part of a premarket notification filed by The See Clear Company, Inc with the FDA for See Clear Soft Contact Lens, See Clear Color Soft Contact Lens, Fierce Soft Contact Lens.
| Device ID | K111345 |
| 510k Number | K111345 |
| Device Name: | SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | THE SEE CLEAR COMPANY, INC 16576 W. 53rd Way Golden, CO 80403 |
| Contact | Kevin Randall |
| Correspondent | Kevin Randall THE SEE CLEAR COMPANY, INC 16576 W. 53rd Way Golden, CO 80403 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-13 |
| Decision Date | 2011-11-02 |
| Summary: | summary |