FDA.reportPublic FDA data

OPMI® LUMERA® 300

Primary DI
06909262061375
Brand
OPMI® LUMERA® 300
Company
Carl Zeiss Suzhou Co., Ltd.
Model
6137
Device description
No description
Published
2022-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSOMicroscope, Surgical, General & Plastic Surgery
HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06909262061375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06909262061375069092620613756909262061375

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, surgicalAn electrically-powered ophthalmic magnification instrument, usually stereoscopic, designed for use in the operating room (OR) to magnify minute structures within the eye or its surroundings in the performance of ophthalmic surgical procedures which require high magnification by transmitted light. It is typically equipped with motorized focusing, adjustable magnification mechanisms (zoom), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528182577
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
06909262200156Zeiss AxiovertAxiovert 5431030-9050-0002026-05-19
06909262060330EXTARO® 30060332022-08-11
06909262060347EXTARO® 30060342022-08-11
06909262060354EXTARO® 30060352022-08-11
06909262100104EXTARO® 300000000-2327-7552022-08-11
06909262200040ZEISS Axio VertAxio Vert.A1431030-9000-0002021-01-01
06909262200057ZEISS Axio VertAxio Vert.A1431030-9010-0002021-01-01
06909262200064ZEISS Axio VertAxio Vert.A1431030-9040-0002021-01-01
06909262200118ZEISS Axio LabAxio Lab.A1430037-9010-0002021-01-01
06909262200125ZEISS Axio LabAxio Lab.A1430037-9020-0002021-01-01
06909262200231ZEISS AxiolabAxiolab 5430037-9011-0002021-01-01
06909262200248ZEISS AxiolabAxiolab 5430037-9021-0002021-01-01
06909262200286ZEISS AxiolabAxiolab 5430037-9060-0002021-01-01
06909262200293ZEISS AxiolabAxiolab 5430037-9070-0002021-01-01
06909262200316ZEISS Axio LabAxio Lab.A1430037-9000-0002021-01-01
06909262200323ZEISS AxioscopeAxioscope 5430035-9032-0002021-01-01
06909262200330ZEISS AxioscopeAxioscope 5430035-9061-0002021-01-01
06909262200378ZEISS AxioscopeAxioscope 5430035-9201-0002021-01-01
06909262200422ZEISS AxioscopeAxioscope 5430035-9261-0002021-01-01
06909262200460ZEISS AxiolabAxiolab 5430037-9110-0002021-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04064434000209Heidelberg OPERAMunich Surgical Imaging GmbHHRM2026-05-14
00811608019970Mounting Kit, for Kaps SOM62VOLK OPTICAL INC.FSO2026-04-27
00811608019987ROLS Adapter Kit, for KapsVOLK OPTICAL INC.FSO2026-04-27
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
00860011130734SurgiSight™ Digital Visualization HeadsetUnify Medical Inc.FSO2025-12-02
00860011130741SurgiSight™ Digital Visualization SystemUnify Medical Inc.FSO2025-12-02
00454745102558INAMIINAMI & CO., LTD.HRM2025-11-12
04547451081777INAMIINAMI & CO., LTD.HRM2025-11-12
06945095524779zumaxZumax Medical Co., LTDFSO2025-10-28
06945095524991zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525097zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525134zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525462zumaxZumax Medical Co., LTDFSO2025-10-28