Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5842](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5842) → HQZ — Frame, Spectacle

# HQZ · Frame, Spectacle

_Ophthalmic · 21 CFR 886.5842 · Class 1_

**Canonical URL:** https://fda.innolitics.com/productcode/HQZ

## Overview

- **Product Code:** HQZ
- **Device Name:** Frame, Spectacle
- **Regulation:** [21 CFR 886.5842](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5842)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

## Recent Cleared Devices (20 of 198)

Showing 20 most recent of 198 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K952597](/device/K952597.md) | VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW | Point of View Optical Outlet, Inc. | Sep 12, 1995 | SESE |
| [K944313](/device/K944313.md) | SPECTACLE FRAME | Sun Hing Optical Manufactory , Ltd. | Mar 28, 1995 | SESE |
| [K945770](/device/K945770.md) | OPTICAL FRAMES | Ramada Optics, Inc. | Dec 15, 1994 | SESE |
| [K945392](/device/K945392.md) | SPECTACLE FRAME | Seo Han Corp., Ltd. | Dec 15, 1994 | SESE |
| [K945176](/device/K945176.md) | SPECTACLE FRAME OR EYEGLASS FRAMES | Optipia Trading Co. | Dec 15, 1994 | SESE |
| [K945350](/device/K945350.md) | FRAME, SPECTACLES | Taiwan Eva Industrial Co., Inc. | Dec 13, 1994 | SESE |
| [K945342](/device/K945342.md) | MAG-1 SPECTACLE FRAME | Criss Optical Mfg. Co., Inc. | Nov 28, 1994 | SESE |
| [K945450](/device/K945450.md) | FRAME, SPECTACLE | Kookje Apis Industrial Co. | Nov 22, 1994 | SESE |
| [K945340](/device/K945340.md) | SPECTACLE FRAMES OR EYEGLASS FRAMES | Mi Mun Corp. | Nov 22, 1994 | SESE |
| [K945323](/device/K945323.md) | SPECTACLE FRAME | M.Y. Vision Corp. | Nov 22, 1994 | SESE |
| [K945123](/device/K945123.md) | ARISTAR EYEWEAR, ESPRIT EYEWEAR | Aristar Inc. U.S.A. | Nov 22, 1994 | SESE |
| [K944641](/device/K944641.md) | NIL | Max-Vision (H.K.)Limited | Nov 14, 1994 | SESE |
| [K944373](/device/K944373.md) | SPECTACLE FRAMES | Custom Optical Frames, Inc. | Sep 28, 1994 | SESE |
| [K944160](/device/K944160.md) | SILHOUETTE, SUNLIMETED,ADIDAS | Silhouette Optical , Ltd. | Sep 28, 1994 | SESE |
| [K943792](/device/K943792.md) | SPECTACLE FRAMES | Kt Optique, Inc. | Sep 14, 1994 | SESE |
| [K943641](/device/K943641.md) | SPECTACLE FRAME | Australian Optical Co., Inc. | Sep 14, 1994 | SESE |
| [K943561](/device/K943561.md) | SPECTACLE FRAME | Australian Optical Co., Inc. | Sep 14, 1994 | SESE |
| [K943913](/device/K943913.md) | MAX FRAME DESIGN | Noble Optic | Sep 7, 1994 | SESE |
| [K943423](/device/K943423.md) | SPECTACLE FRAMES | Galilee Optics | Sep 6, 1994 | SESE |
| [K943753](/device/K943753.md) | FRAME SPECTACLE | Optic Tech Corp. | Sep 2, 1994 | SESE |

## Top Applicants

- Australian Optical Co., Inc. — 5 clearances
- Frontier Novelty, Inc. — 4 clearances
- South West Intl., Inc. — 4 clearances
- Roseburg SA — 3 clearances
- Atlantic Optical Co., Inc. — 2 clearances

---

**Source:** [https://fda.innolitics.com/productcode/HQZ](https://fda.innolitics.com/productcode/HQZ)

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