FDA product code MMQ: Topographer, Corneal, Ac-Powered
MMQ is the FDA product code for topographer, corneal, ac-powered. It is a Class I device, regulated under 21 CFR 886.1350 and reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under MMQ, from 5 different applicants. The average 510(k) review took 149 days (median 155).
Classification
| Field | Value |
|---|---|
| Device name | Topographer, Corneal, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MMQ clearance
Top MMQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Medical Sciences, Inc. | 1 | 1998-12-07 |
| Euclid Systems Corp. | 1 | 1997-05-20 |
| Orbtek, Inc. | 1 | 1997-03-26 |
| Eclipse Ventures | 1 | 1996-12-23 |
| Par Vision Systems Corp. | 1 | 1995-06-14 |
Most recent MMQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K981665 | Bio-Medical Sciences, Inc. | SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE | 1998-12-07 | 210 |
| K964702 | Euclid Systems Corp. | EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 | 1997-05-20 | 176 |
| K964891 | Orbtek, Inc. | ORBSHOT KERATOMETER | 1997-03-26 | 110 |
| K963762 | Eclipse Ventures | CORNEAL TOPOGRAPHER 200 | 1996-12-23 | 95 |
| K950077 | Par Vision Systems Corp. | INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) | 1995-06-14 | 155 |
Recalls for MMQ devices
openFDA lists no recalls for product code MMQ.
Frequently asked questions
What is FDA product code MMQ?
MMQ is the FDA product code for topographer, corneal, ac-powered. It is a Class I device, regulated under 21 CFR 886.1350 and reviewed by the Ophthalmic panel.
What device class is MMQ?
Class I, regulation 21 CFR 886.1350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MMQ?
Across 5 cleared submissions the average was 149 days from receipt to decision (median 155).
Which companies have the most MMQ clearances?
Bio-Medical Sciences, Inc. (1); Euclid Systems Corp. (1); Orbtek, Inc. (1); Eclipse Ventures (1); Par Vision Systems Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MMQ
- Run a recall and safety report across every MMQ manufacturer
- Watch product code MMQ 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.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times