The following data is part of a premarket notification filed by Optical Connection, Inc. with the FDA for 55 Uv (methafilcon A) Soft (hydrophilic) Contact Lens For Daily Wear.
| Device ID | K051095 |
| 510k Number | K051095 |
| Device Name: | 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | OPTICAL CONNECTION, INC. 2091 UPPER SCENIC DRIVE Felton, CA 95018 |
| Contact | Garold L Edwards |
| Correspondent | Garold L Edwards OPTICAL CONNECTION, INC. 2091 UPPER SCENIC DRIVE Felton, CA 95018 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-28 |
| Decision Date | 2005-08-16 |
| Summary: | summary |