FDA 510(k)

LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS

K-Number: K935775 · 1994-03-01

Decision Date1994-03-01

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS 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 1994-03-01 under 510(k) number K935775. 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 LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS?

LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS is a medical device that received FDA 510(k) clearance on 1994-03-01. The listed applicant is Heraeus Surgical, Inc.. The 510(k) number is K935775.

When did LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS receive FDA 510(k) clearance?

LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS received FDA 510(k) clearance on 1994-03-01, under 510(k) number K935775.

Who is the listed applicant for LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS?

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 LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS?

The FDA product code for LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS is GEX. This falls under the Gastroenterology category.

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Other records listing Heraeus Surgical, 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.