NFM · Expander, Tissue, Orbital
Ophthalmic · 21 CFR 886.3320 · Class 2
Overview
| Product Code | NFM |
|---|---|
| Device Name | Expander, Tissue, Orbital |
| Regulation | 21 CFR 886.3320 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| Implant | Yes |
Identification
An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.
Classification Rationale
Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K060151 | ORBITAL TISSUE EXPANDER (OTE) | Innovia, LLC | Aug 8, 2006 | SESE |
| K010852 | OSMED TISSUE EXPANDER | Iop, Inc. | Aug 13, 2001 | SESE |
Top Applicants
- Iop, Inc. — 1 clearance
- Innovia, LLC — 1 clearance
