CORE EXPERTISE

Expertise in products with complex mechanisms

Our expertise is organised around actual mechanisms, with particular focus on microcurrent, ultrasound, ion-air, radiofrequency, and other products that are difficult to distinguish at the medical/non-medical boundary.

RFEnergy-based Devices

Radiofrequency Beauty Devices

Address the relationship among RF output, skin temperature rise, mechanism, use setting and medical-style claims.

  • Frequency and waveform
  • Output power and energy
  • Skin temperature rise and depth of action
  • Boundaries for delivery, tightening and treatment
MCElectrical-stimulation Devices

Microcurrent and EMS Devices

Align product parameters and intended purpose for microcurrent, pulsed-current, muscle-stimulation and skin-care applications.

  • Current and voltage
  • Frequency and pulse waveform
  • Electrode contact method
  • Boundary between muscle stimulation and treatment
USDelivery Devices

Ultrasound and Beauty-delivery Devices

Address product-definition issues involving ultrasound frequency, intensity, coupling media, delivery purposes and tissue effects.

  • Ultrasound frequency and intensity
  • Cavitation and thermal effects
  • Coupling media
  • Evidence for delivery claims
LEDLight-energy Devices

Light-based Beauty Devices

Address energy, temperature rise, skin response and intended-purpose boundaries for LED, broad-spectrum and other light-based beauty devices.

  • Wavelength and spectrum
  • Energy density
  • Exposure distance and duration
  • Skin safety and claim boundaries
EPTransdermal-delivery Devices

Electroporation and Pneumatic-delivery Devices

Assess the actual action and regulatory pathway of delivery devices using electrical pulses, pneumatic jets, consumable liquids and skin contact.

  • Electrical-pulse or pneumatic parameters
  • Skin integrity
  • Liquids and consumables
  • Evidence of non-invasiveness
COMCombination Devices

Combination Beauty Devices

Systematically assess multifunction devices combining RF, microcurrent, ultrasound, light, heating/cooling, vacuum and vibration.

  • Principal mechanism
  • Independent or linked functions
  • Worst-case parameter combinations
  • Overall intended purpose
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