← Product Code [HQH](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH) · K952538 # ROBERT B. SCOTT PLASTIC ARTIFICAL (K952538) _Robert B. Scott Ocularists of Florida, Inc. · HQH · Jun 26, 1995 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH/K952538 ## Device Facts - **Applicant:** Robert B. Scott Ocularists of Florida, Inc. - **Product Code:** [HQH](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH.md) - **Decision Date:** Jun 26, 1995 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.3200 - **Device Class:** Class 1 - **Review Panel:** Ophthalmic ## Regulatory Identification An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted. --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH/K952538](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH/K952538) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH/K952538