Fluobeam Lm Fblm

Fluobeam Lm Fblm is a Class I device made by Fluoptics, cleared under FDA 510(k) K190891 on 31 Jul 2019 and listed in FDA GUDID since 18 Feb 2021 (UDI-DI B475FBLM0), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB475FBLM0 UDI-DI	Date18 Feb 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK190891	Date31 Jul 2019Issued	StatusActive

Official records

FDA 510(k) database 510(k) number K190891

Across registries

2 registries list this device

FDA 510(k) K190891 decided 31 Jul 2019 Active
FDA GUDID UDI-DI B475FBLM0 listed 18 Feb 2021 Listed

Timeline

2 dated events

31 Jul 2019 Cleared FDA 510(k) K190891
18 Feb 2021 Listed FDA GUDID B475FBLM0

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Fluobeam Lm
Generic name: Diagnostic-imaging multiformat camera
Model / reference: FBLM

Primary DI / UDI-DI: B475FBLM0
FDA product code: QGD
GMDN term: Diagnostic-imaging multiformat camera

Device class: Class I
Regulation number: 876.5290
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Combination product
Serial number
Manufacturing date

Other properties (11, all answered No)