Certifications

For DermRays V4S, V8S: FDA√  UKCA√  CE√

1. USA Food & Drug Administration (FDA)
  • V4S and V8S
  • Device
Clearance Number: K230090
Trade / Device Name: Diode Laser Hair Removal
Model: LHR-V8S-810, LHR-V4S-810
Clearance Date: April 19, 2023
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: OHT
  • Performance Data
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of Diode Laser Hair Removal was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The testing was performed to, and passed, including:
ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-10:2010, Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization
    2) Electrical, EMC, and laser output, Safety and Performance Testing
    Electrical, EMC, and laser output, Safety and Performance Testing was performed to, and passed, the following standards:
    IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance
    IEC 60601-1-11 Medical electrical equipment –Part 1-11: General requirements for basic safety and essential performance –Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
    IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility – Requirements and tests
    IEC 60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    IEC 60825-1 Safety of laser products - Part 1: Equipment classification, and requirements
      2. UK Conformity Assessed (UKCA)
      • V4S
      Registration No.: AT18250EC300582
      Report No.: 18250EC30058201
      Product: Diode Laser Hair Removal
      Test Model No.: LHR-V4S-810
      Rating: AC220V, 50Hz,1.6A Max
      Date: Jun.27, 2023
        • V8S
        Registration No.: AT18250EC300580
        Report No.: 18250EC30058001
        Product: Diode Laser Hair Removal
        Test Model No.: LHR-V8S-810
        Rating: AC220V-230V, 50Hz, 2.1A Max
        Date: Jun.27, 2023
          3. Conformite Europeenne (CE)
          • V4S
          Registration No.: AT18250EC300581
          Report No.: 18250EC30058101
          Product: Diode Laser Hair Removal
          Test Model No.: LHR-V4S-810
          Rating: AC220V, 50Hz,1.6A Max
          Date: Jun.27, 2023
            • V8S
            Registration No.: AT18250EC300579
            Report No.: 18250EC30057901
            Product: Diode Laser Hair Removal
            Test Model No.: LHR-V8S-810
            Rating: AC220V-230V, 50Hz, 2.1A Max
            Date: Jun.27, 2023

              For DermRays V6S: FDA√  CE√

              1. USA Food & Drug Administration (FDA)
              Clearance Number: K232117
              Trade / Device Name: Diode Laser Hair Removal
              Model: LHR-V6S-1064, LHR-V6S/B-1064
              Clearance Date: November 28, 2023
              Regulation Number: 878.4810
              Regulation Medical Specialty: General & Plastic Surgery
              510k Review Panel: General & Plastic Surgery
              Product Code: OHT
              2. Conformite Europeenne (CE)
              Registration No.: AT18250EC301245
              Report No.: 18250EC30124501
              Product: Diode Laser Hair Removal
              Test Model No.: LHR-V6S-1064
              Rating: 100-240V~, 50/60Hz, 1.6AMax
              Date: Dec.12, 2023