Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control System
FDA 510(k) K132475 · Fluoptics
510(k) numberK132475
Submission
- Device name
- Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control System
- Applicant
- Fluoptics
Orinda, CA, US - Received
- August 7, 2013
- Decision date
- May 7, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWN – Confocal Optical Imaging
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Collection of light signals for visualization of cellular microstructures.
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Questions and answers
When was Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control System cleared by the FDA?
Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control System (K132475) received a 510(k) decision of Substantially Equivalent on May 7, 2014, 273 days after the submission was received.
What is the product code of K132475?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.