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FDA 510(k)

MODEL MD-25 CO2 LASER FOR NEUROSURGERY USE

K-Number: K881585 · 1988-06-03

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

Device Summary

MODEL MD-25 CO2 LASER FOR NEUROSURGERY 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 K881585. 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 CO2 LASER FOR NEUROSURGERY USE?

MODEL MD-25 CO2 LASER FOR NEUROSURGERY 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 K881585.

When did MODEL MD-25 CO2 LASER FOR NEUROSURGERY USE receive FDA 510(k) clearance?

MODEL MD-25 CO2 LASER FOR NEUROSURGERY USE received FDA 510(k) clearance on 1988-06-03, under 510(k) number K881585.

Who is the listed applicant for MODEL MD-25 CO2 LASER FOR NEUROSURGERY 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 CO2 LASER FOR NEUROSURGERY USE?

The FDA product code for MODEL MD-25 CO2 LASER FOR NEUROSURGERY USE is GEX. This falls under the Gastroenterology category.

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Other records listing Laser Engineering, 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.

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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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