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FDA 510(k)

LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH.

K-Number: K920334 · 1993-03-31

ApplicantLaser Photonics, Inc.
Decision Date1993-03-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH. 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 1993-03-31 under 510(k) number K920334. 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 LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH.?

LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH. is a medical device that received FDA 510(k) clearance on 1993-03-31. The listed applicant is Laser Photonics, Inc.. The 510(k) number is K920334.

When did LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH. receive FDA 510(k) clearance?

LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH. received FDA 510(k) clearance on 1993-03-31, under 510(k) number K920334.

Who is the listed applicant for LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH.?

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 LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH.?

The FDA product code for LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH. is GEX. This falls under the Gastroenterology category.

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Other records listing Laser Photonics, Inc. as applicant

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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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