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FDA 510(k)

SPECTRA-SP CO2 LASER SYSTEM

K-Number: K050254 · 2005-04-15

ApplicantMax Engineering , Ltd.
Decision Date2005-04-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPECTRA-SP CO2 LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Max Engineering , Ltd.. It received FDA 510(k) clearance on 2005-04-15 under 510(k) number K050254. 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 SPECTRA-SP CO2 LASER SYSTEM?

SPECTRA-SP CO2 LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2005-04-15. The listed applicant is Max Engineering , Ltd.. The 510(k) number is K050254.

When did SPECTRA-SP CO2 LASER SYSTEM receive FDA 510(k) clearance?

SPECTRA-SP CO2 LASER SYSTEM received FDA 510(k) clearance on 2005-04-15, under 510(k) number K050254.

Who is the listed applicant for SPECTRA-SP CO2 LASER SYSTEM?

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

What is the FDA product code for SPECTRA-SP CO2 LASER SYSTEM?

The FDA product code for SPECTRA-SP CO2 LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Max Engineering , Ltd. 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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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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