HOI — Spectacle, Magnifying Class I
FDA product code HOI covers "Spectacle, Magnifying", a Class I medical device regulated under 21 CFR 886.5840. Submissions are reviewed by the Ophthalmic panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HOI
- Device Class
- Class I
- Regulation Number
- 886.5840
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K943613 | sing wah international enterprises | NIL | September 21, 1994 |
| K930435 | venis di a. vendrame | SPECTACLE FRAMES | September 20, 1993 |
| K931328 | pyramid | PYRAMID SUNGLASSES/PYRAMID READING GLASSES | August 10, 1993 |
| K910329 | cutler and gross sloan optical | SUNGLASSES | March 12, 1991 |
| K854854 | int'l eye care | SYSTEMS OF SIGHT LOW VISION EYEWARE | February 4, 1986 |
| K844716 | gazelle | MAGNIFYING SPECTACLES W/PLASTIC LENSES | January 3, 1985 |
| K844038 | visitec | VISITEC MAGNIFYING SPECTACLES | November 29, 1984 |
| K842835 | cillus company | BRILLETTE MODEL | November 21, 1984 |
| K820732 | peter m. tolliver | LA VEL LATERAL VIEW EXTENSION LENS | May 3, 1982 |
| K813548 | bacou usa, inc. and uvex safety | UVEX MINI-SPECS | March 2, 1982 |
| K801733 | robert e. fenzl, m.d | FENZL RETICLE | September 16, 1980 |