BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Iridex 810 Laser

    K Number: K202760 · Decision Oct 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    9
    Review Days
    30

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Iridex 810 Laser
    K Number
    K202760
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Iridex Corporation
    Date Received
    September 21, 2020
    Decision Date
    October 21, 2020
    Product Code
    HQF
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQF Laser, Ophthalmic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HQF), ordered by most recent decision date.

    Voyager DSLT (430840610)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    INTEGRE LIO

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Navilas Laser System 577sl (156691)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    EyeQ nanoECP

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Leos Laser and Endoscopy System

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LYNX Photocoagulator

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by Iridex Corporation

    K Number Device Name
    K230228 Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)
    K223132 Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
    K213592 Iridex 810 Laser
    K181662 Iridex TruFocus LIO Premiere
    K170718 Iridex TruFocus LIO Premiere
    K162416 IRIDEX Cyclo G6 Laser System, G-Probe Illuminate
    K143154 IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)
    K041930 VARILITE LASER SYSTEM