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510(k) Data Aggregation
K Number
K971193Device Name
LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM
Manufacturer
POLYTEC PI, INC.
Date Cleared
1997-06-24
(84 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
POLYTEC PI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LaseAway Long Pulse and Q-Switched Ruby Laser System is intended to remove blue/black tattoos and benign dermal and epidermal piqmented lesions, and, to effect hair removal of patients with skin types 1:4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
Device Description
Using a wavelength of 694 nm., the LaseAway Long Pulse and Q-Switched Ruby Laser System consists of a Long Pulse and Q-Switched ruby laser together with an articulated delivery arm and focusing optics. The laser parameters are managed by an analog control unit which is coupled to the main system and calibration is facilitated by an energy detector in the front panel. The pulse operation is initiated by a footswitch and a visible helium neon laser to provide guidance for accurate beam delivery.
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