510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190891Substantially Equivalent

Fluobeam LX

Fluoptics, Grenoble Cedex 9, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190891 is the FDA 510(k) clearance record for Fluobeam LX, a class II device, cleared for Fluoptics on under FDA product code QDG (Parathyroid Autofluorescence Imaging Device). FDA's definition for product code QDG reads: "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". FDA records list 3 510(k) clearances for Fluoptics, from to . As of , FDA records show no recalls naming K190891.

Clearance record

Decision date
Received
(117 days to decision)
Product code
QDG Parathyroid Autofluorescence Imaging Device
Regulation
21 CFR 878.4550
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Fluoptics 7 Parvis Louis Neel, Cs 20050, Grenoble Cedex 9, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QDG

Trailing 12 months
1 clearance under product code QDG in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QDG, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260