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
Jul 06, 1998
CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
Valleylab, Inc.
General & Plastic Surgery
90d
Cleared
May 18, 1998
OLYMPUS SONOSURG SYSTEM
The Olympus Optical Co.
General & Plastic Surgery
347d
Cleared
Apr 09, 1998
ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5))
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
87d
Cleared
Dec 10, 1997
B.U.S. ENDOTRON
Medicamat S.A.
General & Plastic Surgery
184d
Cleared
Dec 09, 1997
UAS ULTRASONIC ASPIRATOR SYSTEM
Wells Johnson Co.
General & Plastic Surgery
223d
Cleared
Aug 14, 1997
SCULPTURE
Servizi Medico Estetici Italinai Srl.
General & Plastic Surgery
105d
Cleared
Jul 25, 1997
VIBRA-SURGE SYSTEM MODEL VS2120
Sonics & Materials, Inc.
General & Plastic Surgery
88d
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
Apr 22, 1997
RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM
Aziz Y. Anis, M.D.
General & Plastic Surgery
147d
Cleared
Jan 16, 1997
CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY
Valleylab, Inc.
General & Plastic Surgery
59d
Cleared
Nov 04, 1996
ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
126d
Cleared
Sep 19, 1996
ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM
Morwel Corp.
General & Plastic Surgery
84d
Cleared
Jun 28, 1996
ULTRACUT 2000
Ultralase Technologies, Inc.
General & Plastic Surgery
154d
Cleared
Apr 29, 1996
SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE
Sharplan Lasers, Inc.
General & Plastic Surgery
118d
Cleared
Jul 11, 1995
CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS
Valleylab, Inc.
General & Plastic Surgery
664d
Cleared
Apr 10, 1995
COOPER LASER SONICS CUSA MODEL 200
Valleylab, Inc.
General & Plastic Surgery
82d
Cleared
Nov 09, 1994
SONOCA III
Holl Meditronics, Inc.
General & Plastic Surgery
203d
Cleared
Sep 16, 1994
CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS.
Valleylab, Inc.
General & Plastic Surgery
515d
Cleared
Oct 15, 1993
ALLIGER ULTRASONIC SURGICAL SYSTEM
Medsonic, Inc.
General & Plastic Surgery
85d
Cleared
Oct 12, 1993
CV720-727-000, MICROTIP AND FLUE PAK
Valleylab, Inc.
General & Plastic Surgery
102d
Cleared
Jul 21, 1993
BOVIE ULTRASONIC SURGICAL ASPIRATOR
Mdt Corp., Inc.
General & Plastic Surgery
82d
Cleared
Jun 12, 1992
CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATOR
Valleylab, Inc.
General & Plastic Surgery
88d