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510(k) Data Aggregation
K Number
K120527Device Name
ALPHA ORTHOPAEDICS AT2 SYSTEM
Manufacturer
Date Cleared
2012-06-18
(117 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ALPHA ORTHOPAEDICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AT2 System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Device Description
The AT2 System utilizes monopolar radiofrequency energy for coagulation and to induce tissue changes in dermatologic and general surgical procedures. It consists of a RF generator, cooling module, handpiece, and sterile disposable single-patient use treatment electrodes. It uses accessories including coupling fluid, return pad, coolant canister, and skin marking paper. The AT2 System applies to specific areas of the body radiofrequency energy while cooling the surface of the tissue in contact with the treatment electrode and uses dielectric as the method of applying radiofrequency via the treatment electrode. This submission adds treatment electrodes that have electrode patient contact surface area of 0.25cm² and 1.50cm².
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