leica-microsystems.comLeica FL400
Leica Microsystems (Schweiz) AG
LEICA MICROSYSTEMS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1423337 | 3000210133 | LEICA MICROSYSTEMS, INC. | 1 | Y | 2026-01-01 | 10 Parkway North Blvd. Suite 300 Deerfield IL US 60015 |
| 3003893952 | 3003893952 | LEICA MICROSYSTEMS CMS GMBH | 1 | N | 2026-01-01 | ERNST-LEITZ-STRASSE 17-37 WETZLAR Hesse DE 35578 |
| 3006809695 | 3006809695 | Leica Microsystems NC, Inc. | 1 | N | 2026-01-01 | 4222 Emperor Blvd Suite 390 Durham NC US 27703 |
| 1423337 | 3000210133 | LEICA MICROSYSTEMS, INC. | 1 | Y | 2020-04-25 | 1700 Leider Ln Buffalo Grove IL US 60089 |
| 3006809695 | 3006809695 | Leica Microsystems NC, Inc. | 1 | N | 2020-04-25 | 4222 Emperor Blvd Suite 390 Durham NC US 27703 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07630003568707 | M822 Optics Carrier - M822 Set Optics Carrier - for Leica surgical operating microscope systems: M822 F20, M822 F40, M822 C40, M822 CT40 | +1(847)8213502 | Andrew.Suchomski@leica-microsystems.com |
| 07630003568707 | M822 Optics Carrier - M822 Set Optics Carrier - for Leica surgical operating microscope systems: M822 F20, M822 F40, M822 C40, M822 CT40 | +1(984)7105152 | Iris.Pohl@leica-microsystems.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 282782 | 1998945142 | K162783 | EnFocus 2300, EnFocus 4400 | OBO | 2016-12-09 |
| 282782 | 1181537441 | K150722 | EnFocus 2300, EnFocus 4400 | HLI | 2015-12-02 |
| 88108 | 1520719325 | K150722 | EnFocus 2300, EnFocus 4400 | HLI | 2015-12-02 |
| 88108 | 1791953058 | K120057 | ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) | HLI | 2012-05-11 |
| 88108 | 1896629300 | K063343 | BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM | HLI | 2006-12-13 |
| 207390 | 1357057235 | ||||
| 207390 | 1392062066 | ||||
| 207390 | 1904457887 |
Product Codes Associated With Registrations#
PMN#
GLOW800
Leica Microsystems (Schweiz) AG
Leica FL560
LEICA MICROSYSTEMS (SCHWEIZ) AG
LEICA FL800
LEICA MICROSYSTEMS (SCHWEIZ) AG
LEICA MODEL FL800
LEICA MICROSYSTEMS, INC.
PORTABLE NON-CONTACT TONOMETER, MODEL PT100
LEICA MICROSYSTEMS, INC. O.I.D.
LEICA AT550
LEICA MICROSYSTEMS, INC.
GUDID#
PROvido - PROvido Stand (Standard) - for Leica surgical operating microscope system: PROvido
2020-08-04
PROvido - PROvido stand (Premium) - for Leica surgical operating microscope system: PROvido
2020-08-04
M530 OHX - OHX Stand for M530 - for Leica surgical operating microscope system: M530 OHX
2020-08-06
FL400 - FL400 for M530 - Accessory for Leica surgical operating microscope systems
2020-09-10
PROVEO 8 CT42 - Ceiling swingarm for PROVEO 8 - for Leica surgical operating microscope system: PROVEO 8 CT42
2020-09-22
PROVEO 8 F42 - PROVEO 8 Stand F42 - for Leica surgical operating microscope system: PROVEO 8
2020-09-22
PROVEO 8 Optics Carrier - PROVEO Optics Carrier - for Leica surgical operating microscope systems: PROVEO 8
2020-09-22
M822 Optics Carrier - M822 Set Optics Carrier - for Leica surgical operating microscope systems: M822 F20, M822 F40, M822 C40, M822 CT40
2020-09-22
M620 F20 - F20 Stand system for M620 - for Leica surgical operating microscope system: M620 F20
2020-09-22
M525 Optics Carrier - Optics carrier M525 - for Leica surgical operating microscope systems: M525 F20, M525 CT20
2020-09-22
M525 F20 - Floorstand System F20 for M525 - for Leica surgical operating microscope system: M525 F20
2020-09-22
M822 C40 / M822 CT40 / M844 C40 / M844 CT40 - C40 Ceiling swingarm for M822 - for Leica surgical operating microscope systems: M822 C40, M822 CT40
2020-09-22
M844 F40 / M822 F40 - F40 stand for M822 - for Leica surgical operating microscope systems: M822 F40
2020-09-22
M844 Optics Carrier - M844 Set Optics carr./focus/XY assistant - for Leica surgical operating microscope systems: M844 F20, M844 F40, M844 CT40, M844 C40
2020-09-22
M620 TTS - Table Top System for M620 - for Leica surgical operating microscope system: M620 TTS
2020-09-22
M620 Optics Carrier - M620 Set Optics carrier,focus, tilt - for Leica surgical operating microscope systems: M620 F20, M620 TTS
2020-09-22
Leica Keratoscope - Leica Keratoscope - Accessory for Leica surgical operating microscope systems
2020-09-25
Wireless Footswitch 12-functions - Wireless Footswitch 12-functions Type B - Accessory for Leica surgical operating microscope systems
2021-06-15
Wireless Footswitch 14-functions - Wireless Footswitch 14-functions Type B - Accessory for Leica surgical operating microscope systems
2021-06-15
M220 F12 - M220 set microscope, stand, footswitch - for Leica surgical operating microscope system: M220 F12
2021-06-22
ARveo 8 - ARveo 8 stand system for M530 microscope - for Leica surgical operating microscope system: ARveo 8
2021-10-08
PROVEO 8 F42 - PROVEO 8 Stand F42, OCT Ready variant - for Leica surgical operating microscope system: PROVEO 8
2020-11-09
Leica RUV800 WD200 - RUV800 WD200 - Accessory for Leica surgical operating microscope systems
2022-08-19
RUV800 WD175 - RUV800 WD175 - Accessory for Leica surgical operating microscope systems
2022-08-19
MyVeo Headset - MyVeo Headset - additional Headset to MyVeo Connection Hub
2024-05-02
MyVeo - MyVeo - Complete device including the Connection Hub, all Connection Cables and one MyVeo Headset
2024-05-03
ARveo 8 - ARveo 8 stand system for M530 microscope - for Leica surgical operating microscope system: ARveo 8
2024-05-03
M844 F20 / M822 F20 - F20 stand system for M822 - for Leica surgical operating microscope systems: M822 F20
2021-07-30
CaptiView - CaptiView, Image Injection Module - Accessory for Leica surgical operating microscope systems
2020-09-22
Leica FL800 ULT - 000000000010448761
2016-09-08
LEICA FL800 - 000000000010448748
2016-09-13
LEICA FL800 - 000000000010448715
2016-09-08
LEICA FL800 - 000000000010448713
2016-09-08
ARveo - ARveo stand system for M530 microscope - for Leica surgical operating microscope system: ARveo
2020-08-12
Leica DI C800 - Leica DI C800 - Accessory for Leica surgical operating microscope systems
2020-09-22
DI C500 - DI C500, Dual Imaging Color module. FL - Accessory for Leica surgical operating microscope systems
2020-09-22
M525 CT20 - Swing Stand System M525 CT20 - for Leica surgical operating microscope system: M525 CT20
2020-09-22
M320 Optics Carrier - M320 Optics Carrier, Swing arm short, inclined - for Leica surgical operating microscope systems: M320 FP12, M320 F12, M320 TP12, M320 LW12, M320 TC12
2021-06-22
M320 Optics Carrier - M320 Optics Carrier, Swing Arm, perpendicular C/W12 - for Leica surgical operating microscope systems: M320 W12, M320 C12, M320 LW12
2021-06-22
M320 Optics Carrier - M320 Optics Carrier, Swing Arm, inclined C/W12 - for Leica surgical operating microscope systems: M320 W12, M320 C12, M320 LW12
2021-06-22