LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K212082
    Device Name
    Picore
    Manufacturer
    Bio-Med USA Inc
    Date Cleared
    2021-10-06

    (96 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K171648
    Why did this record match?
    Device Name :

    Picore

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PICORE Q-switched Nd : Y AG Laser System is indicated for the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

    532nm Wavelength
    Tattoo removal light ink (red, tan, purple, orange, sky blue) Removal of Benign Epidermal Pigmented Lesions, Minor Benign Vascular Lesions. Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi, Freckles Treatment of Post Inflammatory Hyperpigmentation (PIH)

    1064nm Wavelength:
    Tattoo removal: dark ink (black, blue, green) Removal of Nevus of Ota, Removal or lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi, Melasma, Skin resurfacing procedures for the treatment of acne scars. wrinkle

    Device Description

    The subject device PICORE is a picosecond Nd:Y AG laser instrument that uses Nd:YAG as a medium to emit a laser beam of 1064nm and 532nm wavelength. It has four non-fractional handpieces (Zoom handpiece, 7mm collimated handpiece, 3-5 mm handpiece, 6-8 mm handpiece). A physician can optimize the treatment effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam. Laser emission can be controlled by using a Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device (BM.IRIS, K171648) by showing that its technical specifications are comparable and that it passed relevant non-clinical testing standards.

    However, we can infer the "acceptance criteria" through the comparison to the predicate device and the non-clinical testing performed.

    Acceptance Criteria (Inferred)Reported Device Performance (PICORE, K212082)
    Technical Specifications Comparable to Predicate Device (BM.IRIS, K171648):
    Laser TypeNd:YAG (Same as predicate)
    Wavelength (nm)1064/532 (Same as predicate)
    Operating ModeQ-switched, Pulsed (Same as predicate)
    Spot size (mm)2-10 @ 1064nm, 2-10 @ 532nm (Comparable to predicate's 2-10 @ 1064nm, 1.5-8 @ 532nm)
    Maximum Pulse Energy (mJ)50-800 @ 1064nm (Q), 5-300 @ 532nm (Q), 50-800 @ Blue Fx, 50-800 @ Blue T (Different from predicate's 1200 @1064nm (Q), 400 @ 532nm (Q), etc., but noted as "different & subset" with an implication of maintaining safety/effectiveness).
    Maximum Pulse Power (GW)800 mJ/450ps = 1.8 GW (Different from predicate's 1200 mJ/5ns = 0.24 GW, but deemed not to significantly alter safety/effectiveness).
    Pulse Duration450 ps @ 1064nm, 380 ps @ 532nm, 450 ps @ Blue Fx, 450 ps @ Blue T (Different from predicate's 5-10ns, but deemed not to significantly alter safety/effectiveness).
    Repetition Rate (Hz)1-10 (Different from predicate's 10-20, but noted as "different & subset" with an implication of maintaining safety/effectiveness).
    Aiming Beam
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1