HOI · Spectacle, Magnifying
Ophthalmic · 21 CFR 886.5840 · Class 1
Overview
| Product Code | HOI |
|---|---|
| Device Name | Spectacle, Magnifying |
| Regulation | 21 CFR 886.5840 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.
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 § 866.9.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K943613 | NIL | Sing Wah International Enterprises , Ltd. | Sep 21, 1994 | SESE |
| K930435 | SPECTACLE FRAMES | Venis DI A. Vendrame | Sep 20, 1993 | SESE |
| K931328 | PYRAMID SUNGLASSES/PYRAMID READING GLASSES | Pyramid | Aug 10, 1993 | SESE |
| K910329 | SUNGLASSES | Cutler & Gross Sloan Optical , Ltd. | Mar 12, 1991 | SESE |
| K854854 | SYSTEMS OF SIGHT LOW VISION EYEWARE | Int'L Eye Care, Inc. | Feb 4, 1986 | SESE |
| K844716 | MAGNIFYING SPECTACLES W/PLASTIC LENSES | Gazelle Corp. | Jan 3, 1985 | SESE |
| K844038 | VISITEC MAGNIFYING SPECTACLES | Visitec Co. | Nov 29, 1984 | SESE |
| K842835 | BRILLETTE MODEL | Cillus Company, Inc. | Nov 21, 1984 | SESE |
| K820732 | LA VEL LATERAL VIEW EXTENSION LENS | Peter M. Tolliver | May 3, 1982 | SESE |
| K813548 | UVEX MINI-SPECS | Bacou USA, Inc. and Uvex Safety, Inc. | Mar 2, 1982 | SESE |
| K801733 | FENZL RETICLE | Robert E. Fenzl, M.D. | Sep 16, 1980 | SESE |
Top Applicants
- Bacou USA, Inc. and Uvex Safety, Inc. — 1 clearance
- Cillus Company, Inc. — 1 clearance
- Cutler & Gross Sloan Optical , Ltd. — 1 clearance
- Gazelle Corp. — 1 clearance
- Int'L Eye Care, Inc. — 1 clearance
