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FDA 510(k)

URANUS, COMFORTOUCH LASER SYSTEM

K-Number: K001031 · 2000-06-29

ApplicantLaser Max Medical Technologies Corp.
Decision Date2000-06-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

URANUS, COMFORTOUCH LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Laser Max Medical Technologies Corp.. It received FDA 510(k) clearance on 2000-06-29 under 510(k) number K001031. 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 URANUS, COMFORTOUCH LASER SYSTEM?

URANUS, COMFORTOUCH LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2000-06-29. The listed applicant is Laser Max Medical Technologies Corp.. The 510(k) number is K001031.

When did URANUS, COMFORTOUCH LASER SYSTEM receive FDA 510(k) clearance?

URANUS, COMFORTOUCH LASER SYSTEM received FDA 510(k) clearance on 2000-06-29, under 510(k) number K001031.

Who is the listed applicant for URANUS, COMFORTOUCH LASER SYSTEM?

The FDA 510(k) record lists Laser Max Medical Technologies Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URANUS, COMFORTOUCH LASER SYSTEM?

The FDA product code for URANUS, COMFORTOUCH LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Laser Max Medical Technologies Corp. 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.

K952046LMT 20 AA LASER SURGICAL SYSTEMK952047LMT 40 AA LASER SURGICAL SYSTEMK952045LMT 20 HH LASER SURGIVAL SYSTEM

Related Devices (Code: GEX)

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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