510(k) K190891
K190891 is an FDA 510(k) premarket notification submitted by Fluoptics for the device "Fluobeam LX". The FDA issued a decision of Substantially Equivalent on Jul 31, 2019. 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
- SESE (Substantially Equivalent)
- Decision Date
- Jul 31, 2019
- Date Received
- Apr 5, 2019
- Clearance Type
- Traditional
- 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.