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FDA 510(k)

COOL LASER OPTICS (CLO) UNIT

K-Number: K934486 · 1994-03-24

ApplicantCyruschess
Decision Date1994-03-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOL LASER OPTICS (CLO) UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Cyruschess. It received FDA 510(k) clearance on 1994-03-24 under 510(k) number K934486. 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 COOL LASER OPTICS (CLO) UNIT?

COOL LASER OPTICS (CLO) UNIT is a medical device that received FDA 510(k) clearance on 1994-03-24. The listed applicant is Cyruschess. The 510(k) number is K934486.

When did COOL LASER OPTICS (CLO) UNIT receive FDA 510(k) clearance?

COOL LASER OPTICS (CLO) UNIT received FDA 510(k) clearance on 1994-03-24, under 510(k) number K934486.

Who is the listed applicant for COOL LASER OPTICS (CLO) UNIT?

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

What is the FDA product code for COOL LASER OPTICS (CLO) UNIT?

The FDA product code for COOL LASER OPTICS (CLO) UNIT is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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