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FDA 510(k)

OPELASER PRO II AND THE OPELASER LITE II

K-Number: K120932 · 2012-12-07

ApplicantThe Yoshida Dental Mfg. Co., Ltd.
Decision Date2012-12-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPELASER PRO II AND THE OPELASER LITE II is the device name listed in this FDA 510(k) record. The listed applicant is The Yoshida Dental Mfg. Co., Ltd.. It received FDA 510(k) clearance on 2012-12-07 under 510(k) number K120932. 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 OPELASER PRO II AND THE OPELASER LITE II?

OPELASER PRO II AND THE OPELASER LITE II is a medical device that received FDA 510(k) clearance on 2012-12-07. The listed applicant is The Yoshida Dental Mfg. Co., Ltd.. The 510(k) number is K120932.

When did OPELASER PRO II AND THE OPELASER LITE II receive FDA 510(k) clearance?

OPELASER PRO II AND THE OPELASER LITE II received FDA 510(k) clearance on 2012-12-07, under 510(k) number K120932.

Who is the listed applicant for OPELASER PRO II AND THE OPELASER LITE II?

The FDA 510(k) record lists The Yoshida Dental Mfg. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPELASER PRO II AND THE OPELASER LITE II?

The FDA product code for OPELASER PRO II AND THE OPELASER LITE II is GEX. This falls under the Gastroenterology category.

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Related Devices (Code: GEX)

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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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