HMR · Class I · 21 CFR 886.4570

FDA Product Code HMR: Marker, Ocular

Leading manufacturers include Refractec, Inc., CooperVision, Inc. and Myocure, Inc..

5
Total
5
Cleared
169d
Avg days
1986
Since

FDA 510(k) Cleared Marker, Ocular Devices (Product Code HMR)

5 devices
1–5 of 5
Cleared Mar 03, 2006
OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
K053475
Refractec, Inc.
Ophthalmic · 79d
Cleared Aug 29, 1994
OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS
K925606
Chiron Vision Corp.
Ophthalmic · 662d
Cleared Oct 20, 1986
OPHTHALMIC SURGICAL OCULAR MARKERS
K863663
Myocure, Inc.
Ophthalmic · 32d
Cleared May 14, 1986
OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU
K861535
CooperVision, Inc.
Ophthalmic · 20d

About Product Code HMR - Regulatory Context