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FDA 510(k)

MULTILASE 45

K-Number: K904227 · 1990-12-12

ApplicantLaser Photonics, Inc.
Decision Date1990-12-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MULTILASE 45 is the device name listed in this FDA 510(k) record. The listed applicant is Laser Photonics, Inc.. It received FDA 510(k) clearance on 1990-12-12 under 510(k) number K904227. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTILASE 45?

MULTILASE 45 is a medical device that received FDA 510(k) clearance on 1990-12-12. The listed applicant is Laser Photonics, Inc.. The 510(k) number is K904227.

When did MULTILASE 45 receive FDA 510(k) clearance?

MULTILASE 45 received FDA 510(k) clearance on 1990-12-12, under 510(k) number K904227.

Who is the listed applicant for MULTILASE 45?

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

What is the FDA product code for MULTILASE 45?

The FDA product code for MULTILASE 45 is GEX. This falls under the Gastroenterology category.

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Other records listing Laser Photonics, Inc. as applicant

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Related Devices (Code: GEX)

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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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