FDA.reportPublic FDA data

FL400 for M530

Primary DI
07630802403414
Brand
FL400 for M530
Company
Leica Microsystems (Schweiz) AG
Model
10449183
Catalog number
10449183
Device description
FL400 for M530 - Accessory for Leica surgical operating microscope systems
Published
2025-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QFXDiagnostic Neurosurgical Microscope Filter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFXDiagnostic Neurosurgical Microscope FilterNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630802403414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630802403414076308024034147630802403414

GMDN Terms#

Term, Definition table
TermDefinition
Surgical microscope filterAn electronic accessory to a surgical microscope designed to filter light to enable fluorescence excitation and visualization of tissues treated with an ultraviolet-excitable agent (e.g., aminolaevulinic acid) during open surgical procedures. It is typically used to view gliomas. It may include a computing component with software to allow for the capture of digital images.

Contacts#

Phone, Email table
PhoneEmail
+1(984)7105152Iris.Pohl@leica-microsystems.com

Regulatory Flags#

DUNS number
480198725
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630802402622ARveo 8000000000010449157 104491572024-05-03
07630802403810MyVeo000000000010449167 104491672024-05-03
07630802403827MyVeo Headset000000000010449164 104491642024-05-02
07630003567717RUV800 WD175000000000010448555 104485552022-08-19
07630003567724Leica RUV800 WD200000000000010448556104485562022-08-19
07630003599008PROVEO 8 F42000000000010449058 104490582020-11-09
07630003598872ARveo 8000000000010449063 104490632021-10-08
07630003552188M220 F12000000000010448367104483672021-06-22
07630003580051Wireless Footswitch 14-functions000000000010448846104488462021-06-15
07630003581034Wireless Footswitch 12-functions000000000010448872 104488722021-06-15
07630003570908Leica Keratoscope000000000010448558 104485582020-09-25
07630003524475M620 Optics Carrier000000000010448294 104482942020-09-22
07630003525243M620 TTS000000000010448213 104482132020-09-22
07630003525472M844 Optics Carrier000000000010448197 104481972020-09-22
07630003526233M844 F40 / M822 F40000000000010448142 104481422020-09-22
07630003526295M822 C40 / M822 CT40 / M844 C40 / M844 CT40000000000010448140 104481402020-09-22
07630003551907M525 F20000000000010448284104482842020-09-22
07630003551914M525 Optics Carrier000000000010448300 104483002020-09-22
07630003552195M620 F20000000000010448380104483802020-09-22
07630003568707M822 Optics Carrier000000000010448587104485872020-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049539070159BLUE 400Carl Zeiss Meditec AGQFX2024-10-07
04049539070593BLUE 400 SCarl Zeiss Meditec AGQFX2024-10-07
00816744027728NICO Myriad SPECTRANICO CORPORATIONQFX2024-06-07
00816744027483NICO Myriad SPECTRANICO CORPORATIONQFX2024-04-01
00816744027537NICO Myriad SPECTRANICO CORPORATIONQFX2024-04-01