The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Biofinity (comfilcon A) Soft Contact Lens.
| Device ID | K052560 |
| 510k Number | K052560 |
| Device Name: | BIOFINITY (COMFILCON A) SOFT CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | COOPERVISION, INC. 5870 STONERIDGE DR. SUITE 1 Pleasanton, CA 94588 |
| Contact | Jack P Douglas |
| Correspondent | Jack P Douglas COOPERVISION, INC. 5870 STONERIDGE DR. SUITE 1 Pleasanton, CA 94588 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-16 |
| Decision Date | 2005-12-06 |
| Summary: | summary |