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FDA 510(k)

ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES

K-Number: K023954 · 2003-03-18

ApplicantAltus Medical, Inc.
Decision Date2003-03-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Altus Medical, Inc.. It received FDA 510(k) clearance on 2003-03-18 under 510(k) number K023954. 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 ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES?

ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2003-03-18. The listed applicant is Altus Medical, Inc.. The 510(k) number is K023954.

When did ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES receive FDA 510(k) clearance?

ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES received FDA 510(k) clearance on 2003-03-18, under 510(k) number K023954.

Who is the listed applicant for ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES?

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

What is the FDA product code for ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES?

The FDA product code for ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES is GEX. This falls under the Gastroenterology category.

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Other records listing Altus Medical, Inc. 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.

K033768ALTUS MEDICAL OPTIONAL INFRARED HANDPIECEK022226ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELSK014040FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS

Related Devices (Code: GEX)

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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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