← Product Code [HQZ](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ) · K933133

# SPECTACLE FRAMES (K933133)

_Solitaire Designs, Ltd. · HQZ · Aug 2, 1993 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K933133

## Device Facts

- **Applicant:** Solitaire Designs, Ltd.
- **Product Code:** [HQZ](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ.md)
- **Decision Date:** Aug 2, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5842
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K933133](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K933133)

**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
