FDA.reportPublic FDA data

Labomed Stella OPH microscope with wall mount

Primary DI
08908006463268
Brand
Labomed Stella OPH microscope with wall mount
Company
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Model
6219101
Device description
'- Maxlite coated Motorized 5 Step Zoom, 0.4X, 0.6X, 1.0X, 1.6X, 2.5X- Galilean optical system with high resolution, high depth of field and perfect RedReflex .- 50W LED coaxial illumination (cold light), 100V-240V AC universal power supply- 0° - 210° tiltable binocular head, f-140mm. IPD 49-78mm, configured with DBS (Double beam splitter ), Double iris, MaxLite(TM) optics - f=200mm CMO - WF 10x/18mm eyepieces with diopter lock and foldable eyeguard - Swivel arm (470mm Long, + 180° rotatable altogether with column for better stability and balancing). - suspension arm (1000mm Long, + 180° rotation) with locking knobs, tension control knobs, downward limit stop and LED shut-off in park position - Motorized XYZ carrier with autolock tiltable mechanism, XY reset button and provision for fundus viewing attachment (BIOM image invertor). - 10 function wired foot switch for XY & Z axis movements, Magnification changer and intensity control.- Wall mount- Flip in/out blue blocking yellow filter. Retro illumination contrast stops and retinal protection device. Red free green filter.- can be upgraded with Assistant Viewing Attachment, Camera Adapter and iphone adapters
Published
2023-06-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

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
08908006463268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908006463268089080064632688908006463268

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
919049606
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
08908006463046Labomed Prima DNT Microscope Wall mount61371012022-12-13
08908006463053Labomed Prima DNT Microscope Ceiling Mount61372012022-12-13
08908006463077Labomed Prima DNT Microscope Wall mount long arm61371022022-12-13
08908006463084Labomed Prima DNT Microscope Ceiling Mount Long Arm61372022022-12-13
08908006463091Labomed Prima DNT Microscope Floor Mount Fixed61380012022-12-13
08908006463107Labomed Prima DNT Microscope Floor Mount Fixed Long Arm61380022022-12-13
08908006463114Labomed Magna Floor stand standard arm Microscope61291002022-12-13
08908006463121Labomed Magna Ceiling mount (Standard Arm)61292002022-12-13
08908006463138Labomed Magna Wall mount (Standard Arm)61293002022-12-13
08908006463152Labomed Magna Wall mount (Long Arm)61293012022-12-15
08908006463169Labomed Magna Floor stand with motorized filter (Standard arm)61291012022-12-15
08908006463176Labomed Magna Ceiling mount with motorized filter (Long arm)61292022022-12-15
08908006463183Labomed Magna Wall mount with motorized filter (Long arm)61293022022-12-15
08908006463572LABOMED eVO350 5-Step Slit lamp -Halogen (HL)81263002023-06-17
08908006463251Labomed Stella OPH microscope 62191002023-06-15
08908006463008Labomed Prima ENT microscope 61370002023-06-14
08908006463213Labomed Prima Mu ENT microscope 62120002023-06-14
08908006463244Labomed Magna Ceiling mount (Long Arm)61292012023-06-13
08908006463404Labomed Magna Floor stand with Fluorescence Observation61293042023-06-13
08908006463435Labomed Magna Dental Microscope wall mount long arm / fluorescence observation 61293062023-06-13

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Primary DI, Brand, Company table
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04064434000209Heidelberg OPERAMunich Surgical Imaging GmbHHRM2026-05-14
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00380650008404UNITYAlcon Laboratories, Inc.HRM2026-04-09
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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
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