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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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K Number
K094041Device Name
ALPHA ORTHOPAEDICS AT3 SYSTEM
Manufacturer
Date Cleared
2010-04-07
(98 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ALPHA ORTHOPAEDICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The radiofrequency-energy only delivery components of the Alpha Orthopaedics AT3 System are indicated for use in general surgical procedures for electrocoagulation and hemostasis.
The simultaneous application of radiofrequency energy and skin vibration by the Alpha Orthopaedics AT3 System is indicated for use in:
- General surgical procedures for electrocoagulation and hemostasis .
- . Relief of minor muscle aches and pain
- . Relief of muscle spasms
- Temporary improvement of local circulation (i.e., blood circulation) .
Device Description
The AT3™ System delivers RF energy while cooling tissue by conduction. Components and accessories include the handpiece with vibration, return pad, electronic footswitch (optional), cryogen canister, coupling fluid, skin marking paper, and treatment electrodes.
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K Number
K082956Device Name
ALPHA ORTHOPAEDICS AT2 SYSTEM
Manufacturer
Date Cleared
2008-12-18
(76 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ALPHA ORTHOPAEDICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AT2™ System is indicated for use in General Surgical procedures for electrocoagulation and hemostasis.
Device Description
The AT2™ System consists of a RF generator and accessories, including disposable treatment electrodes.
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