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FDA 510(k)

OCULASE MD

K-Number: K052354 · 2006-07-05

ApplicantBiolase Technology, Inc.
Decision Date2006-07-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OCULASE MD is the device name listed in this FDA 510(k) record. The listed applicant is Biolase Technology, Inc.. It received FDA 510(k) clearance on 2006-07-05 under 510(k) number K052354. 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 OCULASE MD?

OCULASE MD is a medical device that received FDA 510(k) clearance on 2006-07-05. The listed applicant is Biolase Technology, Inc.. The 510(k) number is K052354.

When did OCULASE MD receive FDA 510(k) clearance?

OCULASE MD received FDA 510(k) clearance on 2006-07-05, under 510(k) number K052354.

Who is the listed applicant for OCULASE MD?

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

What is the FDA product code for OCULASE MD?

The FDA product code for OCULASE MD 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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