HOIClass I
Spectacle, Magnifying
21 CFR 886.5840 / Ophthalmic
HOI is the FDA product code for Spectacle, Magnifying, a class I device type, regulated under 21 CFR 886.5840. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- HOI
- Device name
- Spectacle, Magnifying
- Regulation
- 21 CFR 886.5840
- 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
- 11
- Ingested recalls
- 0
Clearances, product code HOI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1982 | 2 |
| 1984 | 2 |
| 1985 | 1 |
| 1986 | 1 |
| 1991 | 1 |
| 1993 | 2 |
| 1994 | 1 |
Applicants with the most clearances
Product code HOI| Applicant | Clearances |
|---|---|
| Bacou USA, Inc. and Uvex Safety, Inc. | 1 |
| Cillus Company, Inc. | 1 |
| Cutler & Gross Sloan Optical, Ltd. | 1 |
| Gazelle Corp. | 1 |
| Int'L Eye Care, Inc. | 1 |
| Peter M. Tolliver | 1 |
| Pyramid | 1 |
| Robert E. Fenzl, M.D. | 1 |
| Sing Wah International Enterprises, Ltd. | 1 |
| Venis di A. Vendrame | 1 |
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.