MMQ
5 FDA 510(k) clearances · Product code
155 daysmedian time to decision
210 days90th percentile
5clearances measured
FDA profile
- Official device name
- Topographer, Corneal, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1350
- Medical specialty
- Ophthalmic
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE (K981665) | Bio-Medical Sciences, Inc. | 1998-12-07 |
| EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 (K964702) | Euclid Systems Corp. | 1997-05-20 |
| ORBSHOT KERATOMETER (K964891) | Orbtek, Inc. | 1997-03-26 |
| CORNEAL TOPOGRAPHER 200 (K963762) | Eclipse Ventures | 1996-12-23 |
| INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) (K950077) | Par Vision Systems Corp. | 1995-06-14 |
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Every clearance here is in the API, with alerts when new ones post.