FDA 510(k)

AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM

K-Number: K951462 · 1995-06-15

Decision Date1995-06-15

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Allergan Medical Optics. It received FDA 510(k) clearance on 1995-06-15 under 510(k) number K951462. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM?

AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-15. The listed applicant is Allergan Medical Optics. The 510(k) number is K951462.

When did AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM receive FDA 510(k) clearance?

AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM received FDA 510(k) clearance on 1995-06-15, under 510(k) number K951462.

Who is the listed applicant for AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM?

The FDA 510(k) record lists Allergan Medical Optics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM?

The FDA product code for AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM is HQC.

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Other records listing Allergan Medical Optics as applicant

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Related Devices (Code: HQC)

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Official Source

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