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510(k) Data Aggregation

    K Number
    K251981

    Validate with FDA (Live)

    Date Cleared
    2026-01-30

    (217 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K241144

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

    The Boston PICO is indicated for surgical and cosmetic use in dermatology department, general surgery department and plastic surgery department, details are as follows:

    1064 nm wavelength:

    • Remove tattoos of all skin types (Fitzpatrick skin type I-VI) in the following colors: black, brown, green, blue and purple.
    • Treat benign pigmented skin lesions of Fitzpatrick I-IV types.

    532 nm wavelength:

    • Remove tattoos of Fitzpatrick skin type I-III in the following colors: red, yellow and orange.
    • Treat benign pigmented skin lesions of Fitzpatrick I-IV types.

    Microbeam handpieces (1064nm and 532nm) are used for the treatment of wrinkles for skin types I-IV.

    Device Description

    The Boston PICO is a multi-wavelength, pulsed laser system, and a solid-state laser capable of delivering energy at wavelengths of 1064nm, 532nm at extremely short duration in 250ps(± 20%). The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed. The 1064 nm wavelength can be frequency-doubled to 532nm as desired. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532 nm or 1064 nm wavelengths. All these energies are delivered through an articulated arm and corresponding handpiece.

    AI/ML Overview

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