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.

158
Total
158
Cleared
123d
Avg days
1980
Since
158 devices
49–72 of 158
Cleared May 17, 2012
HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23
K120729
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 69d
Cleared Apr 07, 2010
HARMONIC FOCUS SHEARS
K100597
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 36d
Cleared Sep 25, 2007
HARMONIC 10CM COMBINATION HOOK BLADE
K072203
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
K063192
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 102d
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 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 Dec 01, 2004
HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P
K042777
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 56d
Cleared Oct 01, 2001
ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145
K012176
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 81d
Cleared May 31, 2001
ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145
K010898
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 66d
Cleared Dec 15, 2000
ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07
K002906
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 88d
Cleared Mar 17, 2000
ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105
K994280
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
K993054
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 87d
Cleared Mar 12, 1999
ULTRACISION HARMONIC SCALPEL HAND PIECE
K990430
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 29d
Cleared Dec 01, 1998
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM
K983065
Mentor Corp.
General & Plastic Surgery · 90d
Cleared Oct 21, 1998
ULTRACISION 5MM INSTRUMENTS
K983316
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 30d
Cleared Jul 06, 1998
CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K981262
Valleylab, Inc.
General & Plastic Surgery · 90d
Cleared Apr 09, 1998
ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5))
K980099
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 87d
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 Jan 16, 1997
CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY
K964601
Valleylab, Inc.
General & Plastic Surgery · 59d