K-number	K251162
Device name	CUSA® Clarity Ultrasonic Surgical Aspirator System
Applicant	Integra LifeSciences Corporation
Product code	LFL
Device class	Class U
Decision date	Oct 8, 2025
Decision	Substantially Equivalent
Regulation	—

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The CUSA® Clarity Ultrasonic Surgical Aspirator System is an ultrasonically vibrating surgical device that fragments, emulsifies, and removes unwanted soft and hard tissue while preserving delicate structures. It is intended for use in multiple surgical specialties including neurosurgery, gastrointestinal surgery, urological surgery, general surgery, laparoscopic surgery, gynecological surgery, and cardiac surgery where selective tissue dissection is desirable.

Technological characteristics

The subject device has the same technological characteristics as the predicate device. There is no change to the device or its technological characteristics within scope of this premarket notification. The device operates at 23 kHz and 36 kHz ultrasonic frequencies and includes a console, two surgical handpieces, titanium surgical tips, irrigation and suction system, and optional electrosurgical capabilities via CEM Nosecones.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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CUSA® Clarity Ultrasonic Surgical Aspirator System

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