K132796 is an FDA 510(k) clearance for the SUNTOUCH EYE SPEAR. This device is classified as a Sponge, Ophthalmic (Class II - Special Controls, product code HOZ).
Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 30, 2013, 54 days after receiving the submission on September 6, 2013.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4790.
| 510(k) Number | K132796 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2013 |
| Decision Date | October 30, 2013 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HOZ — Sponge, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4790 |