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FDA 510(k)

IMPROVEMENTS TO THE MEHL RUBY LASER

K-Number: K971814 · 1997-08-01

ApplicantMehl/Biophile Intl., Inc.
Decision Date1997-08-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMPROVEMENTS TO THE MEHL RUBY LASER is the device name listed in this FDA 510(k) record. The listed applicant is Mehl/Biophile Intl., Inc.. It received FDA 510(k) clearance on 1997-08-01 under 510(k) number K971814. 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 IMPROVEMENTS TO THE MEHL RUBY LASER?

IMPROVEMENTS TO THE MEHL RUBY LASER is a medical device that received FDA 510(k) clearance on 1997-08-01. The listed applicant is Mehl/Biophile Intl., Inc.. The 510(k) number is K971814.

When did IMPROVEMENTS TO THE MEHL RUBY LASER receive FDA 510(k) clearance?

IMPROVEMENTS TO THE MEHL RUBY LASER received FDA 510(k) clearance on 1997-08-01, under 510(k) number K971814.

Who is the listed applicant for IMPROVEMENTS TO THE MEHL RUBY LASER?

The FDA 510(k) record lists Mehl/Biophile Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPROVEMENTS TO THE MEHL RUBY LASER?

The FDA product code for IMPROVEMENTS TO THE MEHL RUBY LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Mehl/Biophile Intl., Inc. as applicant

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Official Source

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