BIO-EYE II ORBITAL IMPLANT
Device Facts
| Record ID | K003338 |
|---|---|
| Device Name | BIO-EYE II ORBITAL IMPLANT |
| Applicant | Integrated Orbital Implants, Inc. |
| Product Code | HPZ · Ophthalmic |
| Decision Date | Feb 7, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.3320 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
