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510(k) Data Aggregation
K Number
K980895Device Name
ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR
Date Cleared
1998-11-06
(242 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
**CALIFORNIA INSTITUTE OF TISSUE ENG. **& INSTRUMENTI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Allegro is indicated for use in the following surgical specialties when the fragmentation, emulsification and aspiration of soft tissue is desired.
-General Surgery
-Plastic and reconstructive Surgery
Device Description
The Allegro is comprised of a power conditioner (110/120 volts AC), a microcomputer, a control panel, a signal generator, a BNC output, and a separate surgical handpiece. The power conditioner serves to buffer the system from commercial electrical discontinuities and provides a continuous electrical signal to Allegro's components. The microcomputer integrates Allegro's system components and provides a user-friendly control interface. The control panel provides for user input and system settings and displays. The signal generator creates electrical current in programmable waveforms (20-25 kHz). The BNC output connects the system to the surgical handpiece. The surgical handpiece contains the electromotive engine (piezoelectric ceramic stack), the infiltration/aspiration port, and the ultrasonic surgical probe. The electrical waveforms sent to the handpiece excite the motor stack and cause high-frequency, small amplitude motion of the ultrasonic surgical probe. Motion at the tip of the probe fragments local soft tissue, which is then aspirated through the probe.
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