The following data is part of a premarket notification filed by Ocu-ease Optical Products, Inc. with the FDA for Ocu-flex Pediatric Aphakic (ocufilcon B) Spherical Soft Contact Lens For Daily Wear (lathe-cut).
| Device ID | K023077 |
| 510k Number | K023077 |
| Device Name: | OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | OCU-EASE OPTICAL PRODUCTS, INC. 623 GLACIER DR. Grand Junction, CO 81503 |
| Contact | Deanna Werber |
| Correspondent | Deanna Werber OCU-EASE OPTICAL PRODUCTS, INC. 623 GLACIER DR. Grand Junction, CO 81503 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-16 |
| Decision Date | 2002-12-10 |
| Summary: | summary |