Visualase Envision Software System
FDA 510(k) K063505 · Biotex, Inc.
510(k) numberK063505
Submission
- Device name
- Visualase Envision Software System
- Applicant
- Biotex, Inc.
Houston, TX, US - Received
- November 20, 2006
- Decision date
- December 12, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Visualase Envision Software System cleared by the FDA?
Visualase Envision Software System (K063505) received a 510(k) decision of Substantially Equivalent on December 12, 2006, 22 days after the submission was received.
What is the product code of K063505?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.