K991125 is an FDA 510(k) clearance for the SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES. This device is classified as a Accessories, Soft Lens Products (Class II - Special Controls, product code LPN).
Submitted by Sauflon Pharmaceuticals, Ltd. (Chicago, US). The FDA issued a Cleared decision on September 14, 1999, 165 days after receiving the submission on April 2, 1999.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K991125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1999 |
| Decision Date | September 14, 1999 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LPN — Accessories, Soft Lens Products |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5928 |