BEUDAMED
    FDA Registration Active 🇺🇸 United States

    S4OPTIK LLC

    Reg #: 3004441848 · FEI: 3004441848 · Expires 2026
    View on FDA
    Products
    29
    Proprietary Names
    112
    Establishment Types
    2
    Classifications
    29

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    Registration Details

    Registration Name
    S4OPTIK LLC
    Registration Number
    3004441848
    FEI Number
    3004441848
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    11825 Central Parkway
    City
    Jacksonville
    State
    FL
    ZIP
    32224
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132987

    Owner / Operator

    Firm Name
    S4OPTIK LLC
    Operator Number
    9077083
    Address
    11825 Central Parkway
    City
    Jacksonville
    State
    FL
    Postal Code
    32224
    Country
    US
    Correspondent
    Matthew - McKenna

    Products

    Device Name Product Code
    Exophthalmometer HLS
    Camera, Ophthalmic, Ac-Powered HKI
    Keratoscope, Ac-Powered HLQ
    Chair, Ophthalmic, Ac-Powered HME
    Pupillometer, Manual HLH
    Perimeter, Automatic, Ac-Powered HPT
    Microscope, Operating & Accessories, Ac-Powered, Ophthalmic HRM
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Simulatan (Including Crossed Cylinder) HOR
    Gauge, Lens, Ophthalmic HLN
    Table, Instrument, Powered, Ophthalmic HRJ
    Pupillometer, Ac-Powered HLG
    Frame, Trial, Ophthalmic HPA
    Depressor, Orbital HNX
    Tonometer, Manual HKY
    Refractometer, Ophthalmic HKO
    Chart, Visual Acuity HOX
    Set, Lens, Trial, Ophthalmic HPC
    Instrument, Measuring, Lens, Ac-Powered HLM
    Tester, Color Vision HIT
    Projector, Ophthalmic HOS
    Refractor, Manual, Non-Powered, Including Phoropter HKN
    Topographer, Corneal, Ac-Powered MMQ
    Clip, Lens, Trial, Ophthalmic HPB
    Stand, Instrument, Ac-Powered, Ophthalmic HMF
    Lens, Condensing, Diagnostic HJL
    Stool, Operating-Room FZM
    Device, Analysis, Anterior Segment MXK
    Tomography, Optical Coherence OBO

    Proprietary Names

    S4OPTIK EXOPHTHALMOMETER COBRA SIRIUS SCHEIMPHLUG CAMERA MODI' 02 KERATOMETER; Model K-1 JAVAL Ophthalmometer S4OPTIK Examination Chair & Stand - Model 1000-CB-H Marco Bravo 2 Chair - Model BR2-CH-H S4OPTIK Combination Chair & Stand - Model 2000-CB-H S4OPTIK Combination Chair & Stand - Model 2500-CB-H-L S4OPTIK Examination Chair - Model 2000-CH-H S4OPTIK Combination Chair & Stand - Model 1800-CB-H S4OPTIK Combination Chair & Stand - Model 2000-CB-H-L S4OPTIK Examination Chair - Model 2500-CH-H S4OPTIK Examination Chair - Model 1800-CH-H S4OPTIK Combination Chair & Stand - Model 2500-CB-H PUPILOMETER Model PD-1 Perimeter Non-Contact Microscope Fundus Camera Kestrel 3100m; Fundus Camera RetiCam 3100 RS-1000 ZOOM SLITLAMP WITH OPTION CROSS CYLINDER Lens curvature clock PD-1-S4 PD-1 Phantom Table - 240V Instrument table - Atlas Pedestal H-Base Instrument table - Atlas wheelchair Pedestal U-Base Table 3-UP with controller and line-voltage outlets Phantom Table - 120V Table 2-UP with controller and line-voltage outlets Instrument table - Atlas wheelchair Pedestal 230V U-Base Table 2_UP lx with controller and line-voltage outlets Instrument table - Atlas Pedestal 230V H-Base S4OPTIK PUPILOMETER - DIGITAL - PD-1 TRIAL CLIP (Janelli/Halberg) FIXED PD TRIAL FRAME LED Slit Lamp MW50D Zoom Slit Lamp NS-2D with options SL-H5 - LED SL-H5 ELITE HD-LED SL-Z3-LED SL-ZZ - ZOOM - LED SL-Z3 - DIGITAL READY - LED SL-H2 SL-Z2-LED SL-H2-LED SL-HZ - ZOOM - LED SL-H3-LED SL-HZ - ZOOM - DIGITAL READY - LED SL-ZZ - DIGITAL READY - LED SL-Z5-LED SL-Z5 - DIGITAL READY - LED SL-HZ - ZOOM SL-H3-DIGITAL READY-LED SL-H5 - DIGITAL READY-LED SL 990 SL-Z2 SL-Z3 SL-Z5 SL 9900 SL 9800 SL 980 SCERAL DEPRESSOR - Pencil Type GOLDMANN APPLANATION TONOMETER - R900 TYPE TONOMETER; F900 TONOMETER; A900 Auto Refract-Keratometer Speedy-K2 Auto Refractometer Speedy-"i" Hand Held Auto refract Keratometer Retinomax K-plus 3 S4 OPTIK (UNICOS) AUTO REFRACTOR/KERATOMETER-URK-800 Auto Refractokeratometer Speedy-"i" K-model Hand Held ref Retinomax 3 S4 OPTIK (UNICOS) AUTO REFRACTOR/KERATOMETER-URK-700 KERATOMETER; SPEEDY "i" AUTO REFRACTOMETER SPEEDY "i" AUTO REFRACTOMETER Auto Ref-Keratometer REF-K2000 REF TOPO RET-700 VA-1 TRIAL LENS SET AUTO LENSMETER - ALM-Zero S4OPTIK LENSMETER MODEL 90 - VTR A3 Digital Lensmeter AL 2000 ISHIHARA COLOR VISION TEST BOOK CP-2033 CHART PROJECTOR NP-3S CHART PROJECTOR GOLDMANN APPLANATION TONOMETER - 870 TYPE Z800 RT-600-LP-BLK RT-600-SN-GRY Remote Vision RV-II S4OPTIK REFRACTOR MODEL SL-Y100 SL-Y100 Digital Refractor DR 2200 RT-600-SN-BLK RT-600-SP-BLK OPTESTER RT-600-LN-GRY REMOTE VISION RT-600-LN-BLK S4OPTIK ANTARES TOPOGRAPHER Trial Clips S4OPTIK INSTRUMENT STAND - MODEL 1600-ST Lombart CS6 STAND - Model CS-6-ST S4OPTIK 2000-ST S4OPTIK INSTRUMENT STAND - MODEL 2000-ST Marco Bravo 2 Stand-Model BR2-ST Slit Lamp Lenses S4OPTIK POWERED STOOL - MODEL 9000 S4OPTIK Exam Stool with backrest S4OPTIK Exam Stool without backrest MS-39

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility