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
Cleared
Feb 22, 2007
SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM
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
Ethicon Endo-Surgery, LLC
General & Plastic Surgery
102d
Cleared
Jan 03, 2007
AR1000 ULTRASONIC WOUND THERAPY SYSTEM
Arobella Medical, LLC
General & Plastic Surgery
126d
Cleared
Oct 26, 2006
ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF
Misonix, Inc.
General & Plastic Surgery
63d
Cleared
Sep 25, 2006
HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
70d
Cleared
Apr 07, 2006
HARMONIC SCALPEL BLADES AND SHEARS
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
66d
Cleared
Jan 19, 2006
HARMONIC SCALPEL BLADES AND SHEARS
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
80d
Cleared
Aug 22, 2005
RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE
Radionics, A Division of Tyco Healthcare Group LP
General & Plastic Surgery
35d
Cleared
Jun 06, 2005
AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
Misonix, Inc.
General & Plastic Surgery
70d
Cleared
Jun 03, 2005
OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG
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
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
38d
Cleared
Jan 25, 2005
SONOSURG TROCAR
Aomori Olympus Co., Ltd.
General & Plastic Surgery
168d
Cleared
Dec 01, 2004
HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
56d
Cleared
Sep 29, 2004
SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM
Integra Neurosciences, Ltd.
General & Plastic Surgery
37d
Cleared
Sep 08, 2004
SONOSURG ULTRASONIC SURGICAL SYSTEM
Aomori Olympus Co., Ltd.
General & Plastic Surgery
90d
Cleared
Dec 16, 2003
LOTUS
Sra Developments, Ltd.
General & Plastic Surgery
133d
Cleared
Dec 09, 2003
MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM
Misonix, Inc.
General & Plastic Surgery
98d
Cleared
Oct 03, 2003
SONOSURG SYSTEM
The Olympus Optical Co.
General & Plastic Surgery
92d
Cleared
Oct 01, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
Aomori Olympus Co., Ltd.
General & Plastic Surgery
139d
Cleared
Sep 23, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
Olympus Optical Co., Ltd.
General & Plastic Surgery
152d
Cleared
Aug 29, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
Aomori Olympus Co., Ltd.
General & Plastic Surgery
88d
Cleared
Feb 12, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
The Olympus Optical Co.
General & Plastic Surgery
243d
Cleared
Sep 13, 2002
SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
Integra Neurosciences
General & Plastic Surgery
87d
Cleared
Sep 10, 2002
AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
Axya Medical, Inc.
General & Plastic Surgery
90d