Pde Photodynamic Eye
510(k) K110480
Pde Photodynamic Eye is a medical device (FDA Class II; FDA product code OWN, Confocal Optical Imaging) made by Hamamatsu Photonics K.K., cleared under FDA 510(k) K110480 on 13 Jan 2012, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110480 | Date13 Jan 2012 | StatusActive |
Official records
- FDA 510(k) database K110480
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OWN
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K110480
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| PDE C9830-40 | C9830-40 | 04582389010031 | — | On the market |
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Other devices filed under FDA product code OWN (Confocal Optical Imaging).
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