The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Aquasoft (tetrafilcon A) Daily Wear Soft (hydrophilic) Contact Lens.
| Device ID | K954139 |
| 510k Number | K954139 |
| Device Name: | AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | COOPERVISION, INC. 10 FARADAY Irvine, CA 92618 |
| Contact | Amy Blazak |
| Correspondent | Amy Blazak COOPERVISION, INC. 10 FARADAY Irvine, CA 92618 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-01 |
| Decision Date | 1995-11-24 |