The following data is part of a premarket notification filed by Alcon Universal, Ltd. with the FDA for Opti-free Express Lens Drops.
| Device ID | K000385 |
| 510k Number | K000385 |
| Device Name: | OPTI-FREE EXPRESS LENS DROPS |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | ALCON UNIVERSAL, LTD. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Contact | Ralph H Larsen |
| Correspondent | Ralph H Larsen ALCON UNIVERSAL, LTD. 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Product Code | MRC |
| CFR Regulation Number | 886.5918 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-07 |
| Decision Date | 2000-04-28 |