FDA product code HOI: Spectacle, Magnifying
HOI is the FDA product code for spectacle, magnifying. It is a Class I device, regulated under 21 CFR 886.5840 and reviewed by the Ophthalmic panel. FDA has cleared 11 510(k) submissions under HOI, from 11 different applicants. The average 510(k) review took 83 days (median 56).
Classification
| Field | Value |
|---|---|
| Device name | Spectacle, Magnifying |
| Device class | Class I |
| Regulation | 21 CFR 886.5840 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HOI clearance
Top HOI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sing Wah International Enterprises , Ltd. | 1 | 1994-09-21 |
| Venis DI A. Vendrame | 1 | 1993-09-20 |
| Pyramid | 1 | 1993-08-10 |
| Cutler & Gross Sloan Optical , Ltd. | 1 | 1991-03-12 |
| Int'L Eye Care, Inc. | 1 | 1986-02-04 |
6 more applicants have HOI clearances. See the full list in Caduvo.
Most recent HOI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K943613 | Sing Wah International Enterprises , Ltd. | NIL | 1994-09-21 | 56 |
| K930435 | Venis DI A. Vendrame | SPECTACLE FRAMES | 1993-09-20 | 237 |
| K931328 | Pyramid | PYRAMID SUNGLASSES/PYRAMID READING GLASSES | 1993-08-10 | 147 |
| K910329 | Cutler & Gross Sloan Optical , Ltd. | SUNGLASSES | 1991-03-12 | 46 |
| K854854 | Int'L Eye Care, Inc. | SYSTEMS OF SIGHT LOW VISION EYEWARE | 1986-02-04 | 61 |
Recalls for HOI devices
openFDA lists no recalls for product code HOI.
Frequently asked questions
What is FDA product code HOI?
HOI is the FDA product code for spectacle, magnifying. It is a Class I device, regulated under 21 CFR 886.5840 and reviewed by the Ophthalmic panel.
What device class is HOI?
Class I, regulation 21 CFR 886.5840. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOI?
Across 11 cleared submissions the average was 83 days from receipt to decision (median 56).
Which companies have the most HOI clearances?
Sing Wah International Enterprises , Ltd. (1); Venis DI A. Vendrame (1); Pyramid (1); Cutler & Gross Sloan Optical , Ltd. (1); Int'L Eye Care, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HOI
- Run a recall and safety report across every HOI manufacturer
- Watch product code HOI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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