The following data is part of a premarket notification filed by Fluoptics with the FDA for Fluobeam 800 Clinic Laser Imaging Device And Fluocase 800 Control System.
| Device ID | K132475 |
| 510k Number | K132475 |
| Device Name: | FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM |
| Classification | Confocal Optical Imaging |
| Applicant | FLUOPTICS 8 SNOWBERRY COURT Orinda, CA 94563 |
| Contact | Michael A Daniel |
| Correspondent | Michael A Daniel FLUOPTICS 8 SNOWBERRY COURT Orinda, CA 94563 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-08-07 |
| Decision Date | 2014-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B475PVUETSC101 | K132475 | 000 |
| B475FB800CLV190 | K132475 | 000 |
| B475FC800CLV180 | K132475 | 000 |
| B475FC800CLV190 | K132475 | 000 |
| B475FXCLV111 | K132475 | 000 |
| B475PVUEC0A1V100 | K132475 | 000 |
| B475PVUEC0A2V100 | K132475 | 000 |
| B475PVUECCB100 | K132475 | 000 |
| B475PVUECOH100 | K132475 | 000 |
| B475FB800CLV180 | K132475 | 000 |