HMR
5 FDA 510(k) clearances · Product code
53 daysmedian time to decision
662 days90th percentile
5clearances measured
FDA profile
- Official device name
- Marker, Ocular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4570
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1996: 1
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 |
|---|---|---|
| OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 (K053475) | Refractec, Inc. | 2006-03-03 |
| OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS (K925606) | Chiron Vision Corp. | 1994-08-29 |
| LASER CENTERING DEVICE (K872747) | Innomed Corp. | 1987-09-04 |
| OPHTHALMIC SURGICAL OCULAR MARKERS (K863663) | Myocure, Inc. | 1986-10-20 |
| OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU (K861535) | CooperVision, Inc. | 1986-05-14 |
Track HMR automatically
Every clearance here is in the API, with alerts when new ones post.