K073184 is an FDA 510(k) clearance for the BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS. This device is classified as a Lens, Contact (other Material) - Daily (Class II - Special Controls, product code HQD).
Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on February 21, 2008, 100 days after receiving the submission on November 13, 2007.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K073184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2007 |
| Decision Date | February 21, 2008 |
| Days to Decision | 100 days |
| Submission Type | Abbreviated |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQD - Lens, Contact (other Material) - Daily |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5916 |