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510(k) Data Aggregation
K Number
K110304Device Name
APEX ER. YAG / IPL SYSTEM
Manufacturer
SANDSTONE MEDICAL TECHNOLOGIES LLC
Date Cleared
2011-04-08
(65 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SANDSTONE MEDICAL TECHNOLOGIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Er:YAG handpiece is designed specificial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coaqulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications:
Hair Removal (650nm filter) Permanent hair reduction (650nm filter) Treatment of vascular lesions (510nm filter) Treatment of benign pigmented lesions (510 nm filter) Mild to Moderate inflammatory acne (450nm filter)
Device Description
The Apex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. There are 2 handpieces with the system. One is an Er: YAG laser which contains the laser cavity in the head of the handpiece. The second is an Intense Pulsed Light. These handpieces can be removed by the user and interchanged. The Er:YAG Laser energy produced within the device is delivered to the tissue in a wavelength of 2940nm. The Intense Pulsed Light wavelengths are 450nm - 1200nm The user activates laser and IPL emission by means of a footswitch.
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