Visualase Thermal Therapy System
FDA 510(k) K081656 · Biotex, Inc.
510(k) numberK081656
Submission
- Device name
- Visualase Thermal Therapy System
- Applicant
- Biotex, Inc.
Houston, TX, US - Received
- June 12, 2008
- Decision date
- September 10, 2008
- 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 Thermal Therapy System cleared by the FDA?
Visualase Thermal Therapy System (K081656) received a 510(k) decision of Substantially Equivalent on September 10, 2008, 90 days after the submission was received.
What is the product code of K081656?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.