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FDA 510(k)

VISUALASE ENVISION SOFTWARE SYSTEM

K-Number: K063505 · 2006-12-12

ApplicantBiotex, Inc.
Decision Date2006-12-12
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISUALASE ENVISION SOFTWARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biotex, Inc.. It received FDA 510(k) clearance on 2006-12-12 under 510(k) number K063505. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISUALASE ENVISION SOFTWARE SYSTEM?

VISUALASE ENVISION SOFTWARE SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-12. The listed applicant is Biotex, Inc.. The 510(k) number is K063505.

When did VISUALASE ENVISION SOFTWARE SYSTEM receive FDA 510(k) clearance?

VISUALASE ENVISION SOFTWARE SYSTEM received FDA 510(k) clearance on 2006-12-12, under 510(k) number K063505.

Who is the listed applicant for VISUALASE ENVISION SOFTWARE SYSTEM?

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

What is the FDA product code for VISUALASE ENVISION SOFTWARE SYSTEM?

The FDA product code for VISUALASE ENVISION SOFTWARE SYSTEM is LLZ.

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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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