The following data is part of a premarket notification filed by Hamamatsu Photonics, K.k. with the FDA for Pde Photodynamic Eye.
| Device ID | K110480 |
| 510k Number | K110480 |
| Device Name: | PDE PHOTODYNAMIC EYE |
| Classification | Confocal Optical Imaging |
| Applicant | HAMAMATSU PHOTONICS, K.K. 700 13TH STREET, NW SUITE 1200 Washington, DC 20005 |
| Contact | Jeffrey K Shapiro |
| Correspondent | Jeffrey K Shapiro HAMAMATSU PHOTONICS, K.K. 700 13TH STREET, NW SUITE 1200 Washington, DC 20005 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-02-18 |
| Decision Date | 2012-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04582389010031 | K110480 | 000 |