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510(k) Data Aggregation
K Number
K152737Device Name
Lite Touch
Manufacturer
Date Cleared
2016-06-29
(280 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
FOCUS MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Lite Touch™ Er YAG Laser Treatment System is intended for the vaporization, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties:
- · Dermatology
- · Cosmetic surgery
- · Plastic and general surgery
- · Oral surgery
- · Gynecology
- · Otorhinolaryngology
- · Podiatry
Device Description
The Lite Touch™ is an Er:YAG Laser Treatment System intended for use in the vaporization, incision, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties: Dermatology; Cosmetic surgery; Plastic and general surgery; Gynecology; Otorhinolaryngology; and Podiatry.
The Lite Touch™ was previously cleared under K974460 in October 1997. This submission contains an expansion of the previously cleared indications for use. The Lite Touch™ consists of a streamlined, maneuverable cabinet that contains the laser source, control system, power supply and internal cooling system. The laser beam has a light wavelength of 2940nm and is delivered through a counterbalanced articulated arm and hand piece. There is a two stage process of dissimilar actions required to activate the laser beam. The operation of the Lite Touch™ are completely under the physician's control.
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