← Product Code [HQN](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQN) · K772168

# MOLDEYE (K772168)

_Robert B. Scott Ocularists of Florida, Inc. · HQN · Nov 30, 1977 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQN/K772168

## Device Facts

- **Applicant:** Robert B. Scott Ocularists of Florida, Inc.
- **Product Code:** [HQN](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQN.md)
- **Decision Date:** Nov 30, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.3130
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQN/K772168](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQN/K772168)

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