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FDA 510(k)

DL100 C02 SURGICAL LASER SYSTEM

K-Number: K915085 · 1992-02-28

ApplicantMnlase, Inc.
Decision Date1992-02-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DL100 C02 SURGICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mnlase, Inc.. It received FDA 510(k) clearance on 1992-02-28 under 510(k) number K915085. 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 DL100 C02 SURGICAL LASER SYSTEM?

DL100 C02 SURGICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1992-02-28. The listed applicant is Mnlase, Inc.. The 510(k) number is K915085.

When did DL100 C02 SURGICAL LASER SYSTEM receive FDA 510(k) clearance?

DL100 C02 SURGICAL LASER SYSTEM received FDA 510(k) clearance on 1992-02-28, under 510(k) number K915085.

Who is the listed applicant for DL100 C02 SURGICAL LASER SYSTEM?

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

What is the FDA product code for DL100 C02 SURGICAL LASER SYSTEM?

The FDA product code for DL100 C02 SURGICAL LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Mnlase, 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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