LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K241342
    Device Name
    Hair Growth Comb (SZ-23,SZ-23A)
    Manufacturer
    Shenzhen Nuon Medical Equipment Co., Ltd
    Date Cleared
    2024-11-08

    (179 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K230579,K211038,K222477
    Why did this record match?
    Device Name :

    Hair Growth Comb (SZ-23,SZ-23A)

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

    The Hair Growth Comb (Model: SZ-23 ,SZ-23A,) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to 1-4, Il-1, Il-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

    Device Description

    The Hair Growth Comb is (Model: SZ-23, SZ-23A) a comb-shaped device that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 650nm (±10nm) while the comb teeth simultaneously part the user's hair to ensure the light reaches the user's scalp. The device is designed as a handheld product, and it consists of the main unit, the charging dock and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.

    AI/ML Overview

    This document is a 510(k) Summary for a medical device (Hair Growth Comb, Models SZ-23, SZ-23A). It provides information regarding the device's substantial equivalence to previously cleared predicate devices, primarily focusing on its technical characteristics and safety testing.

    Crucially, this document states: "Clinical testing was not needed for this 510(k)." This means that the submission does not include a clinical study designed to prove the device meets specific performance criteria related to the effectiveness of promoting hair growth. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document in the context of device performance regarding its intended clinical effect.

    The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical testing for safety and electrical/software compliance, not clinical efficacy.

    However, I can provide information based on the other aspects of the document:

    Based on the provided 510(k) Summary, the following information can be extracted:

    1. A table of acceptance criteria and the reported device performance:

    As no clinical efficacy study was conducted for this 510(k), there are no clinical performance acceptance criteria and reported device performance related to hair growth in this document. The "acceptance criteria" mentioned are related to safety and functional compliance.

    Acceptance Criteria (Non-Clinical)Reported Device Performance (as stated in document)
    Electrical safety and electromagnetic compatibility:Conforms to voluntary design standards:
    • ANSI/AAMI ES60601-1: 2005 & A1:2012 & A2:2021
    • IEC 60601-1-11: 2015+AMD1:2020
    • IEC 60601-2-57: 2023
    • IEC 60601-1-2: 2014+AMD1:2020
    • IEC 62471: 2006
    • IEC 62133-2: 2017+AMD1:2021
    • IEC 60601-1-6: 2010+AMD1:2013+AMD2:2020
    • IEC 62366-1: 2015+AMD1:2020 |
      | Biocompatibility:
      (for PC+ABS shell, surface-skin contact,
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1