← Product Code [HQZ](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ) · K844658

# SPECTABLE FRAME - PRODESIGN SUN CLUB (K844658)

_Pro Design Intl. AS · HQZ · Dec 11, 1984 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K844658

## Device Facts

- **Applicant:** Pro Design Intl. AS
- **Product Code:** [HQZ](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ.md)
- **Decision Date:** Dec 11, 1984
- **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/K844658](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQZ/K844658)

**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