Product code HMR— Ophthalmic

FDA has cleared 5 devices under product code HMR between 1986 and 2006, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20061 clearance
• 19941 clearance
• 19871 clearance
• 19862 clearances

• Refractec, Inc.1 clearance
• Myocure, Inc.1 clearance
• Innomed Corp.1 clearance
• CooperVision, Inc.1 clearance
• Chiron Vision Corp.1 clearance

• K053475 — OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450Refractec, Inc.·2006-03-03
• K925606 — OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERSChiron Vision Corp.·1994-08-29
• K872747 — LASER CENTERING DEVICEInnomed Corp.·1987-09-04
• K863663 — OPHTHALMIC SURGICAL OCULAR MARKERSMyocure, Inc.·1986-10-20
• K861535 — OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNUCooperVision, Inc.·1986-05-14