510(k) DEN170092
DEN170092 is an FDA 510(k) premarket notification submitted by Fluoptics for the device "Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System". The FDA issued a decision of De Novo Granted on Nov 2, 2018. The device falls under product code QDG (Parathyroid Autofluorescence Imaging Device), a Class II device regulated under 21 CFR 878.4550. Fluoptics has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Nov 2, 2018
- Date Received
- Dec 22, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Parathyroid Autofluorescence Imaging Device
- Device Class
- Class II
- Regulation Number
- 878.4550
- Review Panel
- SU
- Submission Type
An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.