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.

158
Total
158
Cleared
123d
Avg days
1980
Since
158 devices
73–96 of 158
Cleared Nov 04, 1996
ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE
K962584
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 126d
Cleared Apr 29, 1996
SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE
K960040
Sharplan Lasers, Inc.
General & Plastic Surgery · 118d
Cleared Jul 11, 1995
CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS
K934628
Valleylab, Inc.
General & Plastic Surgery · 664d
Cleared Apr 10, 1995
COOPER LASER SONICS CUSA MODEL 200
K950945
Valleylab, Inc.
General & Plastic Surgery · 82d
Cleared Sep 16, 1994
CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS.
K931902
Valleylab, Inc.
General & Plastic Surgery · 515d
Cleared Oct 12, 1993
CV720-727-000, MICROTIP AND FLUE PAK
K933239
Valleylab, Inc.
General & Plastic Surgery · 102d
Cleared Jun 12, 1992
CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATOR
K921251
Valleylab, Inc.
General & Plastic Surgery · 88d
Cleared Jun 11, 1991
CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR
K910696
Valleylab, Inc.
General & Plastic Surgery · 112d
Cleared Jan 19, 1990
CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR
K894600
Valleylab, Inc.
General & Plastic Surgery · 183d
Cleared Oct 14, 1988
SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS
K883091
Sharplan Lasers, Inc.
General & Plastic Surgery · 84d
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