NXM · Prosthesis, Eyelid Spacer/Graft, Biologic
Ophthalmic · 21 CFR 886.3130 · Class 2
Overview
| Product Code | NXM |
|---|---|
| Device Name | Prosthesis, Eyelid Spacer/Graft, Biologic |
| Regulation | 21 CFR 886.3130 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| Implant | Yes |
Identification
An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K090078 | KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT | Iop, Inc. | May 8, 2009 | SESE |
| K053622 | SURGISIS OCULAR GRAFT | Iop, Inc. | Mar 15, 2006 | SESE |
Top Applicants
- Iop, Inc. — 2 clearances
