OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION
Device Facts
| Record ID | K001964 |
|---|---|
| Device Name | OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION |
| Applicant | Lobob Laboratories, Inc. |
| Product Code | MRC · Ophthalmic |
| Decision Date | Jul 18, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 886.5918 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.
Special Controls
*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
