The following data is part of a premarket notification filed by Ocular Sciences Puerto Rico, Inc. with the FDA for Biomedics Uv Colors (ocufilcon D) Soft (hydrophilic) Contact Lens.
| Device ID | K013377 |
| 510k Number | K013377 |
| Device Name: | BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | OCULAR SCIENCES PUERTO RICO, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | Richard Lippman |
| Correspondent | Richard Lippman OCULAR SCIENCES PUERTO RICO, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-12 |
| Decision Date | 2001-12-20 |
| Summary: | summary |