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
73–96 of 160
Cleared Feb 22, 2007
SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM
K063531
Sra Developments, Ltd.
General & Plastic Surgery · 92d
Cleared Jan 30, 2007
HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP
K063192
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 102d
Cleared Jan 03, 2007
AR1000 ULTRASONIC WOUND THERAPY SYSTEM
K062544
Arobella Medical, LLC
General & Plastic Surgery · 126d
Cleared Oct 26, 2006
ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF
K062471
Misonix, Inc.
General & Plastic Surgery · 63d
Cleared Sep 25, 2006
HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S
K062000
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 70d
Cleared Apr 07, 2006
HARMONIC SCALPEL BLADES AND SHEARS
K060245
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 66d
Cleared Jan 19, 2006
HARMONIC SCALPEL BLADES AND SHEARS
K053056
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 80d
Cleared Aug 22, 2005
RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE
K051947
Radionics, A Division of Tyco Healthcare Group LP
General & Plastic Surgery · 35d
Cleared Jun 06, 2005
AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K050776
Misonix, Inc.
General & Plastic Surgery · 70d
Cleared Jun 03, 2005
OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG
K050885
Olympus Medical Systems Corporation
General & Plastic Surgery · 57d
Cleared Jun 02, 2005
HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P
K051036
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 38d
Cleared Jan 25, 2005
SONOSURG TROCAR
K042160
Aomori Olympus Co., Ltd.
General & Plastic Surgery · 168d
Cleared Dec 01, 2004
HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P
K042777
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 56d
Cleared Sep 29, 2004
SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM
K042277
Integra Neurosciences, Ltd.
General & Plastic Surgery · 37d
Cleared Sep 08, 2004
SONOSURG ULTRASONIC SURGICAL SYSTEM
K041566
Aomori Olympus Co., Ltd.
General & Plastic Surgery · 90d
Cleared Dec 16, 2003
LOTUS
K032424
Sra Developments, Ltd.
General & Plastic Surgery · 133d
Cleared Dec 09, 2003
MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K032690
Misonix, Inc.
General & Plastic Surgery · 98d
Cleared Oct 03, 2003
SONOSURG SYSTEM
K032066
The Olympus Optical Co.
General & Plastic Surgery · 92d
Cleared Oct 01, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K031523
Aomori Olympus Co., Ltd.
General & Plastic Surgery · 139d
Cleared Sep 23, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K031305
Olympus Optical Co., Ltd.
General & Plastic Surgery · 152d
Cleared Aug 29, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K031710
Aomori Olympus Co., Ltd.
General & Plastic Surgery · 88d
Cleared Feb 12, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K021962
The Olympus Optical Co.
General & Plastic Surgery · 243d
Cleared Sep 13, 2002
SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
K021989
Integra Neurosciences
General & Plastic Surgery · 87d
Cleared Sep 10, 2002
AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
K021929
Axya Medical, Inc.
General & Plastic Surgery · 90d