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FDA 510(k)

OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM

K-Number: K915651 · 1992-06-15

ApplicantSummit Technology, Inc.
Decision Date1992-06-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Summit Technology, Inc.. It received FDA 510(k) clearance on 1992-06-15 under 510(k) number K915651. 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 OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM?

OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1992-06-15. The listed applicant is Summit Technology, Inc.. The 510(k) number is K915651.

When did OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM receive FDA 510(k) clearance?

OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM received FDA 510(k) clearance on 1992-06-15, under 510(k) number K915651.

Who is the listed applicant for OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM?

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

What is the FDA product code for OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM?

The FDA product code for OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Summit Technology, 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.

K980675SUMMIT KRUMEICH-BARRAQUER MICROKERATOMEK926470LASER AND EMPHASIS SCLEROSTOMY TIPK912522OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDERK904470SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE

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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.

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