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510(k) Data Aggregation

    K Number
    K181253
    Device Name
    Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup
    Manufacturer
    PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC
    Date Cleared
    2018-08-10

    (91 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K122248,K140931,K141567,K142573,K162071,K171895,K122950,K143199
    Why did this record match?
    Device Name :

    Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup

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

    The BOSLEY Revitalizer 272 and 164 Laser Caps are indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-3, or frontal; both with Fitzpatrick Skin Types I to IV.

    Device Description

    The BOSLEY Revitalizer 272 and 164 Laser Caps are low level laser therapy (LLLT) devices designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272 or 164 visible red light-emitting diodes at 650-nm and 5mW each. The lasers are contained inside a lightweight cap. The device is powered by an included battery pack and automatically turns off after 30 minutes.

    AI/ML Overview

    The provided text describes a 510(k) submission for the BOSLEY Revitalizer 272 and 164 Laser Caps. Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the device were primarily related to OTC/Usability Testing and Biocompatibility.

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    OTC/Usability Testing80% success rate in self-selection, comprehension of labeling and instructions, and usability. This includes accurate self-categorization of (a) skin type (I-IV) and (b) hair loss pattern (Norwood-Hamilton IIa-V for males, Ludwig (Savin) I-1 to I-4, II-1, II-3, or frontal for females), to determine candidacy for treatment or contraindication.95% overall of participants correctly judged themselves on hair loss candidacy.
    100% of participants accurately categorized their skin type as suitable for treatment or not suitable when compared with physician ratings.
    100% of women correctly identified their candidacy for treatment or incorrectly judged themselves unsuitable for treatment based on hair loss self-rating.
    90% of men correctly identified their candidacy for treatment or incorrectly judged themselves unsuitable for treatment based on hair loss self-rating (3 males incorrectly identified themselves as treatment candidates).
    Biocompatibility- Material used in manufacturing must be non-cytotoxic.
    • Material must not be a sensitizer for skin contact. | - Cytotoxicity tests demonstrated that the material used in the manufacturing of the caps is non-cytotoxic. The caps met the requirements of ISO 10993-1:2009, ISO 14971:2007, and FDA General Program Memorandum #G95-1, for surface devices with limited contact (
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