The following data is part of a premarket notification filed by Wesley Jessen Corp. with the FDA for Freshlook Bifocal Uv-absorbing (phemfilcon A) Molded Spherical Handling Tint And Colored Soft (hydrophilic0 Contact Lens.
| Device ID | K991550 |
| 510k Number | K991550 |
| Device Name: | FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | WESLEY JESSEN CORP. 333 EAST HOWARD AVE. Des Plaines, IL 60018 |
| Contact | Joseph Foos |
| Correspondent | Joseph Foos WESLEY JESSEN CORP. 333 EAST HOWARD AVE. Des Plaines, IL 60018 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-04 |
| Decision Date | 1999-05-14 |
| Summary: | summary |