FDA 510(k) clearance · back to tracker

FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)

Fluoptics Sas (A Getinge Group Company} cleared K250455 on 2025-04-17, decision: substantially equivalent

K-number

K250455

Sponsor

Fluoptics Sas (A Getinge Group Company}

Device

FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-04-17

Product code

QDG

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4550

Official FDA record

Open K250455on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.