← Product Code [HOY](/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY) · K802786

# POROPLAST-EYE DRESSING (K802786)

_Secol Co. · HOY · Dec 17, 1980 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K802786

## Device Facts

- **Applicant:** Secol Co.
- **Product Code:** [HOY](/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY.md)
- **Decision Date:** Dec 17, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4750
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K802786](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOY/K802786)

**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:** Innolitics at https://innolitics.com
