FDA.reportPublic FDA data

ImageCam 3 (Adapt.: Topcon SL-2E)

Primary DI
04049584026750
Brand
ImageCam 3 (Adapt.: Topcon SL-2E)
Company
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Model
69290
Device description
ImageCam 3 (Adapt.: Topcon SL-2E)
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049584026750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049584026750040495840267504049584026750

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationAn electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye (anterior and posterior surfaces) by viewing through the iris. It produces a narrow slit of powerful light which is projected into the eye, and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular surfaces. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317138956
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049584037909Cable SDI BIOM 6 for Alcon LuxOR Revalia100401382026-02-11
04049584037916Cable Y BIOM 6 for Haag Streit Metis 900100401372026-02-11
04049584037930Cable CAN BIOM 6 for Leica Proveo 8 / 8x100413192026-02-11
04049584037954Cable CTRL BIOM 6 for Leica Proveo 8 / 8x100432282026-02-11
04049584037961Cable Y BIOM 6 for Alcon LuxORRevalia100425572026-02-11
04049584038012Cable CAN BIOM 6 for B&L SeeLuma100428332026-02-11
04049584037695Focusing Module BIOM 6, 175 mm100351102026-01-23
04049584037701Focusing Module BIOM 6, 200 mm100379072026-01-23
04049584037718Precision Mount for B&L100394002026-01-23
04049584037725Precision Mount for Leica100390582026-01-23
04049584037732Precision Mount for Alcon100291772026-01-23
04049584037749Precision Mount for Zeiss100392342026-01-23
04049584037756Precision Mount for Haag Streit100291782026-01-23
04049584035738BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035745BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584037152BIOM 6100348202026-01-14
04049584037251Twinfield 3100348192026-01-14
04049584034229GONIO ready® CL100127192025-05-09
04049584029447BIOM ready+ 175, for f=175 mm544192024-09-11
04049584029454BIOM ready+ 200, for f=200 mm544202024-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015454744RocotoRocoto Inc.KQM2026-02-26
00860015454751RocotoRocoto Inc.KQM2026-02-26
00818089022437RadianceNds Surgical Imaging LLCKQM2026-02-10
08800025400692EZ SHOT SEGOOD DOCTORS CO., LTD.KQM2026-01-15
05415334050020BarcoBarco NVKQM2025-12-22
05415334050013BarcoBarco NVKQM2025-12-01
00819761023032Optik ViewLINDEN GROUP CORPORATION, THEKQM2025-11-25
00819761023049Optik ViewLINDEN GROUP CORPORATION, THEKQM2025-11-24
00860012447107EclipseInnovations Lightx IncKQM2025-11-12
00724995245061HexaVueBLACK DIAMOND VIDEO, INC.KQM2025-10-17
00810000890712FSNFORESEESON CUSTOM DISPLAYS, INC.KQM2025-09-15
04548736170698SONYSONY CORPORATIONKQM2025-09-12
04548736170711SONYSONY CORPORATIONKQM2025-09-12
07613327661194In-Light CameraSTRYKER COMMUNICATIONS INC.KQM2025-08-27
B17731260532L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-23
B17731260532Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-23
B17731260455L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-21
B17731260455Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-21
04995047069867CuratOREIZO CORPORATIONKQM2025-07-18
04995047070320CuratOREIZO CORPORATIONKQM2025-07-18
00840183530402BR Surgical, LLCBR Surgical, LLCKQM2025-07-16
20618125114669SironaTIDI PRODUCTS, LLCKQM2025-07-10
04548736170728SONYSONY CORPORATIONKQM2025-07-08
04548736170742SONYSONY CORPORATIONKQM2025-07-08
06972039971085MOPTIMShenzhen CERTAINN Technology Co., Ltd.KQM2025-06-30
00860014100642AmimonRocoto Inc.KQM2025-06-24
00860014100659AmimonRocoto Inc.KQM2025-06-24
05415334051133SterisBarco NVKQM2025-06-05
04548736167117SONYSONY CORPORATIONKQM2025-05-30
04548736167124SONYSONY CORPORATIONKQM2025-05-30