The following data is part of a premarket notification filed by Johnson & Johnson Vision Care, Inc. with the FDA for Acuvue 2 Brand (etafilcon A) Contact Lens, With Uv Blocker Tinted (to Mask Or Enhance The Natural Iris Color).
| Device ID | K010114 |
| 510k Number | K010114 |
| Device Name: | ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | JOHNSON & JOHNSON VISION CARE, INC. 7500 CENTURION PKWY. Jacksonville, FL 32256 |
| Contact | Sharon Briggs |
| Correspondent | Sharon Briggs JOHNSON & JOHNSON VISION CARE, INC. 7500 CENTURION PKWY. 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 | 2001-01-16 |
| Decision Date | 2001-04-11 |