FDA.reportPublic FDA data

PROVEO 8x

Primary DI
07630802403711
Brand
PROVEO 8x
Company
Leica Microsystems (Schweiz) AG
Model
10449172
Catalog number
10449172
Device description
PROVEO 8x Surgical Microscope
Published
2025-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRMMicroscope, Operating & Accessories, Ac-Powered, OphthalmicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630802403711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630802403711076308024037117630802403711

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical microscopeAn electrically-powered ophthalmic magnification instrument, usually stereoscopic, designed for use in the operating room (OR) to magnify structures within the eye or its surroundings, and/or provide slit-lamp functionality to delineate intraocular structures or defects, during ophthalmic surgical procedures. It can be fixed or mobile (on wheels) and is typically equipped with motorized controls (foot-switch) for adjusting focus, magnification [zoom], illumination, and position, and with articulating arms; some types have integrated video cameras along with digital imaging and user interface screens.

Contacts#

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

Regulatory Flags#

DUNS number
480198725
Device count
1
Premarket exempt
true
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
04064434000209Heidelberg OPERAMunich Surgical Imaging GmbHHRM2026-05-14
00380650008374UNITYAlcon Laboratories, Inc.HRM2026-04-09
00380650008381UNITYAlcon Laboratories, Inc.HRM2026-04-09
00380650008398UNITYAlcon Laboratories, Inc.HRM2026-04-09
00380650008404UNITYAlcon Laboratories, Inc.HRM2026-04-09
04049584037909Cable SDI BIOM 6 for Alcon LuxOR RevaliaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037916Cable Y BIOM 6 for Haag Streit Metis 900OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037930Cable CAN BIOM 6 for Leica Proveo 8 / 8xOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037954Cable CTRL BIOM 6 for Leica Proveo 8 / 8xOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037961Cable Y BIOM 6 for Alcon LuxORRevaliaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584038012Cable CAN BIOM 6 for B&L SeeLumaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-02-11
04049584037695Focusing Module BIOM 6, 175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037701Focusing Module BIOM 6, 200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037718Precision Mount for B&LOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037725Precision Mount for LeicaOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037732Precision Mount for AlconOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037749Precision Mount for ZeissOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037756Precision Mount for Haag StreitOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-23
04049584037152BIOM 6OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHRM2026-01-14
00454745102558INAMIINAMI & CO., LTD.HRM2025-11-12
04547451081777INAMIINAMI & CO., LTD.HRM2025-11-12
04064434000193SeeLuma Digital Binoculars ModuleMunich Surgical Imaging GmbHHRM2025-08-05
06972039971061MOPTIMShenzhen CERTAINN Technology Co., Ltd.HRM2025-06-23
06972039971078MOPTIMShenzhen CERTAINN Technology Co., Ltd.HRM2025-06-23
06972039971221MOPTIMShenzhen CERTAINN Technology Co., Ltd.HRM2025-06-23
01836230004391Microscope Cover MITAKA 137/380 HLTPHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16
01836230004407Microscope Cover MITAKA mm80, mm90, 80/276PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16
02836230004390Microscope Cover MITAKA 137/380 HLTPHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16
02836230004406Microscope Cover MITAKA mm80, mm90, 80/276PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16
00836230004392Microscope Cover MITAKA 137/380 HLTPHARMA SEPT MEDICAL PRODUCTS (1995) LTD.HRM2025-06-16