OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
Device Facts
| Record ID | K001214 |
|---|---|
| Device Name | OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION |
| Applicant | Alcon Universal, Ltd. |
| Product Code | LPN · Ophthalmic |
| Decision Date | Jul 10, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5928 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.
Special Controls
*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
