LFL

FDA Product Code LFL: Instrument, Ultrasonic Surgical

Ultrasonic energy has transformed minimally invasive surgery by providing a single tool for simultaneous cutting and coagulation. FDA product code LFL covers ultrasonic surgical instruments.

These devices use high-frequency mechanical vibrations to cut tissue and coagulate blood vessels simultaneously, with minimal thermal spread and smoke generation compared to electrosurgical devices. They are widely used in laparoscopic, robotic, and open surgical procedures.

LFL devices are reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Ethicon Endo-Surgery, Inc., Ethicon Endo-Surgery, LLC and Integra LifeSciences Corporation.

160
Total
160
Cleared
123d
Avg days
1980
Since
160 devices
145–160 of 160
Cleared Jun 11, 1991
CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR
K910696
Valleylab, Inc.
General & Plastic Surgery · 112d
Cleared Nov 21, 1990
SURGICAL ASPIRATOR KIT
K904010
Surgeon Surgical Instrumentation, Inc.
General & Plastic Surgery · 84d
Cleared Sep 05, 1990
SELECTOR ULTRASONIC SURGICAL ASPIRATOR
K901974
Spembly Medical , Ltd.
General & Plastic Surgery · 127d
Cleared Jul 03, 1990
SONOCA II ULTRASONIC SURGICAL DEVICE
K901737
Holl Meditronics, Inc.
General & Plastic Surgery · 77d
Cleared Jan 19, 1990
CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR
K894600
Valleylab, Inc.
General & Plastic Surgery · 183d
Cleared Nov 14, 1989
SONOCA ULTRASONIC SURGICAL SYSTEM
K893926
Holl Meditronics, Inc.
General & Plastic Surgery · 167d
Cleared Oct 14, 1988
SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS
K883091
Sharplan Lasers, Inc.
General & Plastic Surgery · 84d
Cleared Apr 13, 1988
DX101 ULTRASONIC SURGICAL SYSTEM
K880814
Niic U.S.A., Inc.
General & Plastic Surgery · 56d
Cleared Apr 13, 1988
DX101-T ULTRASONIC SURGICAL SYSTEM
K880815
Niic U.S.A., Inc.
General & Plastic Surgery · 56d
Cleared Feb 18, 1988
BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000
K880166
Clinical Technology Corp.
General & Plastic Surgery · 35d
Cleared Jun 23, 1987
CUSA SYSTEM 200 MACRO-DISSECTOR
K864983
Cooper Lasersonics, Inc.
General & Plastic Surgery · 183d
Cleared Jul 23, 1985
R PAK
K851203
CooperVision, Inc.
General & Plastic Surgery · 119d
Cleared Jul 23, 1985
SUSZOI ULTRASONIC SURGICAL ASPIRATOR SONOP
K852539
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 39d
Cleared Jun 16, 1983
NEEDLE GUIDE MODEL 21285A
K830753
Hewlett-Packard Co.
General & Plastic Surgery · 98d
Cleared Jul 13, 1982
MCSC6PS MEDICAL COMPONENTS
K821820
Medical Components, Inc.
General & Plastic Surgery · 22d
Cleared Nov 18, 1980
CAVITRON ULTRASONIC SURG. ASPIR. CUSA
K801623
Cavitron Corp.
General & Plastic Surgery · 126d