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FDA 510(k)

LASESONICS LOW POWER CO2 LASER SYSTEM

K-Number: K953917 · 1995-10-26

ApplicantHeraeus Surgical, Inc.
Decision Date1995-10-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASESONICS LOW POWER CO2 LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Surgical, Inc.. It received FDA 510(k) clearance on 1995-10-26 under 510(k) number K953917. 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 LASESONICS LOW POWER CO2 LASER SYSTEM?

LASESONICS LOW POWER CO2 LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1995-10-26. The listed applicant is Heraeus Surgical, Inc.. The 510(k) number is K953917.

When did LASESONICS LOW POWER CO2 LASER SYSTEM receive FDA 510(k) clearance?

LASESONICS LOW POWER CO2 LASER SYSTEM received FDA 510(k) clearance on 1995-10-26, under 510(k) number K953917.

Who is the listed applicant for LASESONICS LOW POWER CO2 LASER SYSTEM?

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

What is the FDA product code for LASESONICS LOW POWER CO2 LASER SYSTEM?

The FDA product code for LASESONICS LOW POWER CO2 LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Heraeus Surgical, 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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