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FDA 510(k)

ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A

K-Number: K120377 · 2012-07-25

ApplicantJ. Morita USA, Inc.
Decision Date2012-07-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2012-07-25 under 510(k) number K120377. 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 ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A?

ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A is a medical device that received FDA 510(k) clearance on 2012-07-25. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K120377.

When did ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A receive FDA 510(k) clearance?

ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A received FDA 510(k) clearance on 2012-07-25, under 510(k) number K120377.

Who is the listed applicant for ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A?

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

What is the FDA product code for ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A?

The FDA product code for ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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