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
121–144 of 160
Cleared Jul 06, 1998
CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K981262
Valleylab, Inc.
General & Plastic Surgery · 90d
Cleared May 18, 1998
OLYMPUS SONOSURG SYSTEM
K972114
The Olympus Optical Co.
General & Plastic Surgery · 347d
Cleared Apr 09, 1998
ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5))
K980099
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 87d
Cleared Dec 10, 1997
B.U.S. ENDOTRON
K972148
Medicamat S.A.
General & Plastic Surgery · 184d
Cleared Dec 09, 1997
UAS ULTRASONIC ASPIRATOR SYSTEM
K971580
Wells Johnson Co.
General & Plastic Surgery · 223d
Cleared Aug 14, 1997
SCULPTURE
K971609
Servizi Medico Estetici Italinai Srl.
General & Plastic Surgery · 105d
Cleared Jul 25, 1997
VIBRA-SURGE SYSTEM MODEL VS2120
K971533
Sonics & Materials, Inc.
General & Plastic Surgery · 88d
Cleared Jul 17, 1997
MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS)
K970471
Mentor Corp.
General & Plastic Surgery · 160d
Cleared Jul 07, 1997
ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE
K971302
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 90d
Cleared Jul 01, 1997
ULTRASONIC HAND INSTRUMENTS
K971861
United States Surgical, A Division of Tyco Healthc
General & Plastic Surgery · 42d
Cleared Apr 22, 1997
RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM
K964742
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
K964601
Valleylab, Inc.
General & Plastic Surgery · 59d
Cleared Nov 04, 1996
ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE
K962584
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 126d
Cleared Sep 19, 1996
ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM
K962525
Morwel Corp.
General & Plastic Surgery · 84d
Cleared Jun 28, 1996
ULTRACUT 2000
K960374
Ultralase Technologies, Inc.
General & Plastic Surgery · 154d
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 Nov 09, 1994
SONOCA III
K942095
Holl Meditronics, Inc.
General & Plastic Surgery · 203d
Cleared Sep 16, 1994
CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS.
K931902
Valleylab, Inc.
General & Plastic Surgery · 515d
Cleared Oct 15, 1993
ALLIGER ULTRASONIC SURGICAL SYSTEM
K933559
Medsonic, Inc.
General & Plastic Surgery · 85d
Cleared Oct 12, 1993
CV720-727-000, MICROTIP AND FLUE PAK
K933239
Valleylab, Inc.
General & Plastic Surgery · 102d
Cleared Jul 21, 1993
BOVIE ULTRASONIC SURGICAL ASPIRATOR
K932094
Mdt Corp., Inc.
General & Plastic Surgery · 82d
Cleared Jun 12, 1992
CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATOR
K921251
Valleylab, Inc.
General & Plastic Surgery · 88d