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FDA 510(k)

FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II

K-Number: K003202 · 2001-01-10

ApplicantAltus Medical
Decision Date2001-01-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II is the device name listed in this FDA 510(k) record. The listed applicant is Altus Medical. It received FDA 510(k) clearance on 2001-01-10 under 510(k) number K003202. 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 FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II?

FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II is a medical device that received FDA 510(k) clearance on 2001-01-10. The listed applicant is Altus Medical. The 510(k) number is K003202.

When did FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II receive FDA 510(k) clearance?

FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II received FDA 510(k) clearance on 2001-01-10, under 510(k) number K003202.

Who is the listed applicant for FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II?

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

What is the FDA product code for FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II?

The FDA product code for FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II is GEX. This falls under the Gastroenterology category.

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Other records listing Altus Medical 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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