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FDA 510(k)

COHERENT FLOUROTRON MASTER

K-Number: K811153 · 1981-06-16

ApplicantLumenis, Inc.
Decision Date1981-06-16
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

COHERENT FLOUROTRON MASTER is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 1981-06-16 under 510(k) number K811153. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COHERENT FLOUROTRON MASTER?

COHERENT FLOUROTRON MASTER is a medical device that received FDA 510(k) clearance on 1981-06-16. The listed applicant is Lumenis, Inc.. The 510(k) number is K811153.

When did COHERENT FLOUROTRON MASTER receive FDA 510(k) clearance?

COHERENT FLOUROTRON MASTER received FDA 510(k) clearance on 1981-06-16, under 510(k) number K811153.

Who is the listed applicant for COHERENT FLOUROTRON MASTER?

The FDA 510(k) record lists Lumenis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COHERENT FLOUROTRON MASTER?

The FDA product code for COHERENT FLOUROTRON MASTER is HJO.

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Other records listing Lumenis, Inc. as applicant

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.

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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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