K053622 is an FDA 510(k) clearance for the SURGISIS OCULAR GRAFT. This device is classified as a Prosthesis, Eyelid Spacer/graft, Biologic (Class II - Special Controls, product code NXM).
Submitted by Iop, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on March 15, 2006, 77 days after receiving the submission on December 28, 2005.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3130. For Implantation To Reinforce And Aid In Reconstruction Of The Soft Tissues Of The Eyelid..
| 510(k) Number | K053622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2005 |
| Decision Date | March 15, 2006 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | NXM — Prosthesis, Eyelid Spacer/graft, Biologic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3130 |
| Definition | For Implantation To Reinforce And Aid In Reconstruction Of The Soft Tissues Of The Eyelid. |