HOI
11 FDA 510(k) clearances · Product code
56 daysmedian time to decision
147 days90th percentile
11clearances measured
FDA profile
- Official device name
- Spectacle, Magnifying
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5840
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1993: 1 · 2000: 2 · 2001: 5 · 2002: 1 · 2003: 7 · 2004: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NIL (K943613) | Sing Wah International Enterprises , Ltd. | 1994-09-21 |
| SPECTACLE FRAMES (K930435) | Venis DI A. Vendrame | 1993-09-20 |
| PYRAMID SUNGLASSES/PYRAMID READING GLASSES (K931328) | Pyramid | 1993-08-10 |
| SUNGLASSES (K910329) | Cutler & Gross Sloan Optical , Ltd. | 1991-03-12 |
| SYSTEMS OF SIGHT LOW VISION EYEWARE (K854854) | Int'L Eye Care, Inc. | 1986-02-04 |
| MAGNIFYING SPECTACLES W/PLASTIC LENSES (K844716) | Gazelle Corp. | 1985-01-03 |
| VISITEC MAGNIFYING SPECTACLES (K844038) | Visitec Co. | 1984-11-29 |
| BRILLETTE MODEL (K842835) | Cillus Company, Inc. | 1984-11-21 |
| LA VEL LATERAL VIEW EXTENSION LENS (K820732) | Peter M. Tolliver | 1982-05-03 |
| UVEX MINI-SPECS (K813548) | Bacou USA, Inc. and Uvex Safety, Inc. | 1982-03-02 |
| FENZL RETICLE (K801733) | Robert E. Fenzl, M.D. | 1980-09-16 |
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Every clearance here is in the API, with alerts when new ones post.