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510(k) Data Aggregation

    K Number
    K971821
    Device Name
    UNICA 315 M CO2 SURGICAL LASER SYSTEM
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Date Cleared
    1997-09-25

    (132 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K953074,K951812,K860087
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Unica 315M R/G is indicated for use as a surgical instrument to vaporize, incise, excise, ablate or photocoagulate soft tissue in general surgical procedures

    Device Description
    Weight:33 lb. (15 kg.)
    Dimensions:Length:19.6 in. (49 cm.)Height (folded arm):7.5 in. (18 cm.)Width:6.4 in. (16 cm.)
    Main Laser Source:CO2 laser, sealed wave guide tube TEM00.
    Treatment BeamWavelength:10,600 nm CO2 laser
    Aiming BeamWavelength:532 nm KTP or 635 nm GaAlAs-laser - max. output 5 milliwatt.
    Modes of Operation*:Superpulse/Pulse/ContinuousSingle or Repeat pulse trains
    Beam Delivery:4 joint articulated arm that can be partially folded into the laser.
    Battery backup:Equipped with backup battery for 1 to 5 hours of operationdepending on output power etc.
    Battery charge cycle:Full charge is achieved in 5 hours
    Cooling system:Internal cooling to instrument case. Overheat protection circuit.
    Electric requirements:Single phase 220-230V 50 Hz, <0.5A, orSingle phase 110-120V 60 Hz, <1.0A.
    It contains a sealed laser tube, i.e. no gas filling is needed. The typical life time of the laser . tube is more than 10,000 hours of operation.
    It is mechanically robust and electrically very safe does not contain any higher voltage . than 32 volts.
    It is easy to transport. The 315 M can be hand-carried without difficulty. The articulated . arm can be partially folded into the laser.
    It has a backup battery. The laser output is independent of any line voltage fluctuations or . even total voltage loss for hours.
    It can be connected via micromanipulators to microscopes and colposcopes. Special accessories can be employed, e.g. for angular cutting.
    AI/ML Overview

    The provided text is a Summary of Safety and Effectiveness Information for the Reliant Technologies, Inc. Unica 315M R/G CO2 Laser System, submitted for 510(k) premarket notification. This type of document establishes substantial equivalence to already legally marketed devices, rather than conducting a de novo study to establish new acceptance criteria and prove performance against them.

    Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets them, sample sizes, ground truth establishment, expert adjudication, or MRMC studies.

    Instead, the document focuses on:

    • Device Description: Physical and operational characteristics of the Unica 315M R/G CO2 Laser System.
    • Intended Use: Broad application in general surgical procedures for soft tissue manipulation.
    • Comparison to Predicate Devices: A detailed table comparing the Unica 315M R/G CO2 Laser System's specifications and indications to three legally marketed predicate CO2 laser systems (Luxar - LX-20SP, Coherent System 451, Sharplan 1020).
    • Substantial Equivalence Argument: The core of the 510(k) submission, asserting that the Unica 315M R/G is as safe and effective as the predicate devices based on shared technological characteristics and intended use.

    In summary, this document is a regulatory submission for premarket clearance based on substantial equivalence, not a clinical study report proving performance against defined acceptance criteria.

    Therefore, I cannot provide the requested table and study details because the information is not present in the provided text.

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