Pde Photodynamic Eye
FDA 510(k) K110480 · Hamamatsu Photonics K.K.
510(k) numberK110480
Submission
- Device name
- Pde Photodynamic Eye
- Applicant
- Hamamatsu Photonics K.K.
Washington Dc, DC, US - Received
- February 18, 2011
- Decision date
- January 13, 2012
- 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 Pde Photodynamic Eye cleared by the FDA?
Pde Photodynamic Eye (K110480) received a 510(k) decision of Substantially Equivalent on January 13, 2012, 329 days after the submission was received.
What is the product code of K110480?
The FDA product code is OWN – Confocal Optical Imaging, a Class II (moderate risk) device regulated under 21 CFR 876.1500.