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FDA 510(k)

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

K-Number: K013756 · 2002-08-29

ApplicantArgus Biomedical Pty, Ltd.
Decision Date2002-08-29
Product CodeHQM
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) is the device name listed in this FDA 510(k) record. The listed applicant is Argus Biomedical Pty, Ltd.. It received FDA 510(k) clearance on 2002-08-29 under 510(k) number K013756. The device is classified under product code HQM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)?

ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) is a medical device that received FDA 510(k) clearance on 2002-08-29. The listed applicant is Argus Biomedical Pty, Ltd.. The 510(k) number is K013756.

When did ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) receive FDA 510(k) clearance?

ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) received FDA 510(k) clearance on 2002-08-29, under 510(k) number K013756.

Who is the listed applicant for ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)?

The FDA 510(k) record lists Argus Biomedical Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)?

The FDA product code for ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) is HQM.

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Related Devices (Code: HQM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182986Boston Keratoprosthesis, Type I LuciaMassachusetts Eye and Ear Infirmary D/B/A BostonK121203BOSTON KERATOPROSTHESIS OR BOSTON KPROMassachusetts Eye & Ear InfirmaryK915062DOHLMAN DOANE KERATOPROTHESISMackeen Consultants, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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