510(k) K090078
K090078 is an FDA 510(k) premarket notification submitted by Iop, Inc. for the device "KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT". The FDA issued a decision of Substantially Equivalent on May 8, 2009. The device falls under product code NXM (Prosthesis, Eyelid Spacer/Graft, Biologic), a Class II device regulated under 21 CFR 886.3130. Iop, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 2009
- Date Received
- January 12, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Eyelid Spacer/Graft, Biologic
- Device Class
- Class II
- Regulation Number
- 886.3130
- Review Panel
- OP
- Submission Type
For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid.