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FDA 510(k)

ERBIUM 2000 LASER FAMILY

K-Number: K972915 · 1997-12-19

ApplicantPhantom Technologies, Inc.
Decision Date1997-12-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ERBIUM 2000 LASER FAMILY is the device name listed in this FDA 510(k) record. The listed applicant is Phantom Technologies, Inc.. It received FDA 510(k) clearance on 1997-12-19 under 510(k) number K972915. 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 ERBIUM 2000 LASER FAMILY?

ERBIUM 2000 LASER FAMILY is a medical device that received FDA 510(k) clearance on 1997-12-19. The listed applicant is Phantom Technologies, Inc.. The 510(k) number is K972915.

When did ERBIUM 2000 LASER FAMILY receive FDA 510(k) clearance?

ERBIUM 2000 LASER FAMILY received FDA 510(k) clearance on 1997-12-19, under 510(k) number K972915.

Who is the listed applicant for ERBIUM 2000 LASER FAMILY?

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

What is the FDA product code for ERBIUM 2000 LASER FAMILY?

The FDA product code for ERBIUM 2000 LASER FAMILY is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Phantom Technologies, 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.

K974633SCANTECH LASER SCANNER

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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