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
Cleared
May 17, 2012
HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23
Ethicon Endo-Surgery, LLC
General & Plastic Surgery
69d
Cleared
Apr 07, 2010
HARMONIC FOCUS SHEARS
Ethicon Endo-Surgery, LLC
General & Plastic Surgery
36d
Cleared
Sep 25, 2007
HARMONIC 10CM COMBINATION HOOK BLADE
Ethicon Endo-Surgery, LLC
General & Plastic Surgery
48d
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
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
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
Dec 01, 2004
HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
56d
Cleared
Oct 01, 2001
ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
81d
Cleared
May 31, 2001
ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
66d
Cleared
Dec 15, 2000
ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
88d
Cleared
Mar 17, 2000
ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
88d
Cleared
Dec 09, 1999
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
87d
Cleared
Mar 12, 1999
ULTRACISION HARMONIC SCALPEL HAND PIECE
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
29d
Cleared
Dec 01, 1998
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM
Mentor Corp.
General & Plastic Surgery
90d
Cleared
Oct 21, 1998
ULTRACISION 5MM INSTRUMENTS
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
30d
Cleared
Jul 06, 1998
CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
Valleylab, Inc.
General & Plastic Surgery
90d
Cleared
Apr 09, 1998
ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5))
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
87d
Cleared
Jul 17, 1997
MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS)
Mentor Corp.
General & Plastic Surgery
160d
Cleared
Jul 07, 1997
ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
90d
Cleared
Jul 01, 1997
ULTRASONIC HAND INSTRUMENTS
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery
42d
Cleared
Jan 16, 1997
CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY
Valleylab, Inc.
General & Plastic Surgery
59d