← Product Code [HQN](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQN) · K921221

# STERILE/SINGLE USE SYMBLEPHARON RING (K921221)

_Storz Instrument Co. · HQN · Jul 17, 1992 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQN/K921221

## Device Facts

- **Applicant:** Storz Instrument Co.
- **Product Code:** [HQN](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQN.md)
- **Decision Date:** Jul 17, 1992
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQN/K921221](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQN/K921221)

**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