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FLUOBEAM LX Red

FDA UDI

Class II (US FDA UDI)

by Fluoptics

Identity

Trade Name
FLUOBEAM LX Red FDA UDI
Generic Name
Intraoperative parathyroid detection system control unit FDA UDI
Device Name
Fluorescence imaging system FDA UDI
Model / Reference
FBLXR FDA UDI
Description
Fluorescence imaging system FDA UDI

Identifiers

Primary DI / UDI-DI
B475FBLXR0 FDA UDI
510(k) Number
K233564 FDA UDI
FDA Product Code
QDG FDA UDI
GMDN Term
Intraoperative parathyroid detection system control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic-imaging multiformat cameraIntraoperative parathyroid detection system control unit

FLUOBEAM LX Red by Fluoptics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraoperative parathyroid detection system control unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fluoptics

Sources (1)

  • FDA UDI 37d06009-3f43-42e9-b9a1-385eb99fedc7 34 fields · synced Jun 8, 2026