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FDA 510(k)

THE ACME MEDICAL AESTHETIC ND:YAG LASER

K-Number: K991234 · 1999-06-28

ApplicantAcme Medical, Inc.
Decision Date1999-06-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE ACME MEDICAL AESTHETIC ND:YAG LASER is the device name listed in this FDA 510(k) record. The listed applicant is Acme Medical, Inc.. It received FDA 510(k) clearance on 1999-06-28 under 510(k) number K991234. 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 THE ACME MEDICAL AESTHETIC ND:YAG LASER?

THE ACME MEDICAL AESTHETIC ND:YAG LASER is a medical device that received FDA 510(k) clearance on 1999-06-28. The listed applicant is Acme Medical, Inc.. The 510(k) number is K991234.

When did THE ACME MEDICAL AESTHETIC ND:YAG LASER receive FDA 510(k) clearance?

THE ACME MEDICAL AESTHETIC ND:YAG LASER received FDA 510(k) clearance on 1999-06-28, under 510(k) number K991234.

Who is the listed applicant for THE ACME MEDICAL AESTHETIC ND:YAG LASER?

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

What is the FDA product code for THE ACME MEDICAL AESTHETIC ND:YAG LASER?

The FDA product code for THE ACME MEDICAL AESTHETIC ND:YAG LASER is GEX. This falls under the Gastroenterology category.

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Official Source

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