K945346 is an FDA 510(k) clearance for the MAKROLON 2405 GOGGLES (LIGHT AND DARK). This device is classified as a Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) (Class I - General Controls, product code HOY).
Submitted by Universal Massage & Tanning, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on November 22, 1994, 20 days after receiving the submission on November 2, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4750.
| 510(k) Number | K945346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1994 |
| Decision Date | November 22, 1994 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HOY — Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4750 |