← Product Code [HPZ](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ) · K003338

# BIO-EYE II ORBITAL IMPLANT (K003338)

_Integrated Orbital Implants, Inc. · HPZ · Feb 7, 2001 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K003338

## Device Facts

- **Applicant:** Integrated Orbital Implants, Inc.
- **Product Code:** [HPZ](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ.md)
- **Decision Date:** Feb 7, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.3320
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K003338](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K003338)

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