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510(k) Data Aggregation
K Number
K072925Device Name
CANDELA-INOLASE SERENITY PRO PSF SYSTEM
Manufacturer
Date Cleared
2008-01-10
(87 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
INOLASE, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System is indicated for the following uses: As an accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration treatment beam through it. Reduction of pain during Laser or Intense Pulse Light System treatment.
Device Description
The Serenity Pro PSF™ System is a device which has the ability to produce a vacuum at a level of 380-680 mbar. Suction can be delivered through its handpiece. which has a sapphire window at its distal end, to be positioned over the skin for laser or IPL treatment. When the PSF system is activated, the negative pressure results in the flattening of the skin of the treatment site. During the time duration of suction, the treatment beam of the laser or IPL is administered through the sapphire window of the handpiece, which is transparent and thermally conductive. The resultant tight mechanical contact produced by the PSF expels blood from the treatment site which enhances the light penetration of the laser or IPL in tissue as well as the removal of its heat from the skin. This can reduce the possibility of post treatment erythema.
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