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FDA-Approval & Indications

FDA Clearance Paves way for Revolutionary New Approach to Treating Nail Fungus

In late September 2011 the Food and Drug Administration provided clearance and approval to the Q-Clear Laser System for the treatment of onychomycosis. In doing so, it made the Q-Clear the very first Q-Switched laser to be specifically approved for this indication, or what is commonly referred to as nail fungus.

US FDA 510(K) 033259 Q-Clear™ Laser

The primary indication for the Q-Switched Q-Clear Laser in podiatry is for the treatment of onychomycosis. However, it has other applications and indications within Podiatry, Family Practice, Dermatology, and Plastic Surgery using both 1064nm and 532nm wavelengths:

1064nm Wavelength – Podiatry, Family Practice

For incision, excision, vaporization, coagulation of soft tissues including:

  • Matrixectomy
  • Warts including periungual, subungual, and plantar warts
  • Radical nail excision
  • Neuromas

1064nm Wavelength – Plastic Surgery, Dermatology

For incision, excision, vaporization, coagulation of soft tissues including:

  • Lesions of the skin and subcutaneous tissue
  • Spider veins
  • Plantar Warts
  • Periungual and subungual warts
  • Debridement of decubitus ulcer
  • Treatment of keloids
  • Dark ink tattoo removal
  • Treatment of pigmented lesions (particularly Nevus of Ota)
  • Removal or lightening of hair
  • Skin resurfacing with or without adjuvant preparation
  • Treatment of common Nevi

532nm Wavelength – Plastic Surgery, Dermatology

For incision, excision, vaporization, coagulation of soft tissues including:

  • Spider veins
  • Removal of light ink (red, tan, purple, and orange) tattoos
  • Treatment of common nevi
  • Treatment of café-au-lait spots
  • Treatment of seborrheic keratoses
  • Treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)
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