Fluoptics is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Fluoptics - FDA 510(k) Cleared Devices
Recent clearances: Fluobeam LX
3
Total
2
Cleared
1
Denied
Fluoptics has 2 FDA 510(k) cleared medical devices. Based in Orinda, US.
Historical record: 2 cleared submissions from 2014 to 2019. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Fluoptics Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Daniel & Daniel Consulting, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Fluoptics
3 devices
Cleared
Jul 31, 2019
Fluobeam LX
General & Plastic Surgery
117d
Not Cleared
Nov 02, 2018
Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System
General & Plastic Surgery
315d
Cleared
May 07, 2014
FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM
General & Plastic Surgery
273d