HQZClass I
Frame, Spectacle
21 CFR 886.5842 / Ophthalmic
HQZ is the FDA product code for Frame, Spectacle, a class I device type, regulated under 21 CFR 886.5842. As of , FDA records hold 198 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- HQZ
- Device name
- Frame, Spectacle
- Regulation
- 21 CFR 886.5842
- Device class
- Class I
- Review panel
- Ophthalmic
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 198
- Ingested recalls
- 1
Clearances, product code HQZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 2 |
| 1979 | 2 |
| 1981 | 3 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 4 |
| 1985 | 4 |
| 1986 | 6 |
| 1987 | 6 |
| 1988 | 4 |
| 1989 | 2 |
| 1990 | 7 |
| 1991 | 11 |
| 1992 | 14 |
| 1993 | 47 |
| 1994 | 80 |
| 1995 | 2 |
Applicants with the most clearances
Product code HQZ| Applicant | Clearances |
|---|---|
| Australian Optical Co., Inc. | 5 |
| Frontier Novelty, Inc. | 4 |
| South West Intl., Inc. | 4 |
| Roseburg SA | 3 |
| Atlantic Optical Co., Inc. | 2 |
| Continental Optical Imports | 2 |
| Kentucky Optical Co. | 2 |
| Oliver Peoples, Inc. | 2 |
| Sam Chung Optical Co., Ltd. | 2 |
| U.S. Optical | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
