DeviceClearance

Product code HQM— Ophthalmic

ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)

Classification name
Keratoprosthesis, Permanent Implant
Device class
Class 2
Regulation
21 CFR 886.3400
Advisory panel
Ophthalmic
Total cleared
4
First cleared
Most recent

Market context for product code HQM

FDA has cleared 4 devices under product code HQM between 1992 and 2019, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code HQM

Recent clearances under product code HQM

Data sourced from openFDA. This site is unofficial and independent of the FDA.