The following data is part of a premarket notification filed by Vistakon with the FDA for Acuvue 2 Colours Brand (etafilcon A) Soft (hydrophilic) Contact Lens With Uv Blocker.
| Device ID | K033969 |
| 510k Number | K033969 |
| Device Name: | ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | VISTAKON 7500 CENTURION PKWY. SUITE 100 Jacksonville, FL 32256 |
| Contact | Annette M Hillring |
| Correspondent | Annette M Hillring VISTAKON 7500 CENTURION PKWY. SUITE 100 Jacksonville, FL 32256 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-22 |
| Decision Date | 2004-02-04 |
| Summary: | summary |