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FDA 510(k)

MODEL MD-25 LASER FOR SURGICAL USE

K-Number: K881588 · 1988-06-03

ApplicantLaser Engineering, Inc.
Decision Date1988-06-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL MD-25 LASER FOR SURGICAL USE is the device name listed in this FDA 510(k) record. The listed applicant is Laser Engineering, Inc.. It received FDA 510(k) clearance on 1988-06-03 under 510(k) number K881588. 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 MODEL MD-25 LASER FOR SURGICAL USE?

MODEL MD-25 LASER FOR SURGICAL USE is a medical device that received FDA 510(k) clearance on 1988-06-03. The listed applicant is Laser Engineering, Inc.. The 510(k) number is K881588.

When did MODEL MD-25 LASER FOR SURGICAL USE receive FDA 510(k) clearance?

MODEL MD-25 LASER FOR SURGICAL USE received FDA 510(k) clearance on 1988-06-03, under 510(k) number K881588.

Who is the listed applicant for MODEL MD-25 LASER FOR SURGICAL USE?

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

What is the FDA product code for MODEL MD-25 LASER FOR SURGICAL USE?

The FDA product code for MODEL MD-25 LASER FOR SURGICAL USE is GEX. This falls under the Gastroenterology category.

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Other records listing Laser Engineering, 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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