K090078 is an FDA 510(k) clearance for the KERASYS BIOENGINEERED LAMELLAR PATCH 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 May 8, 2009, 116 days after receiving the submission on January 12, 2009.
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 | K090078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2009 |
| Decision Date | May 08, 2009 |
| Days to Decision | 116 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. |