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
73–96 of 158
Cleared Dec 01, 2004
HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P
K042777
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 56d
Cleared Sep 29, 2004
SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM
K042277
Integra Neurosciences, Ltd.
General & Plastic Surgery · 37d
Cleared Sep 08, 2004
SONOSURG ULTRASONIC SURGICAL SYSTEM
K041566
Aomori Olympus Co., Ltd.
General & Plastic Surgery · 90d
Cleared Dec 09, 2003
MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K032690
Misonix, Inc.
General & Plastic Surgery · 98d
Cleared Oct 03, 2003
SONOSURG SYSTEM
K032066
The Olympus Optical Co.
General & Plastic Surgery · 92d
Cleared Sep 23, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K031305
Olympus Optical Co., Ltd.
General & Plastic Surgery · 152d
Cleared Feb 12, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K021962
The Olympus Optical Co.
General & Plastic Surgery · 243d
Cleared Sep 10, 2002
AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
K021929
Axya Medical, Inc.
General & Plastic Surgery · 90d
Cleared Aug 23, 2002
ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
K020220
Synergetics, Inc.
General & Plastic Surgery · 213d
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 Jul 27, 2001
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5
K012028
Misonix, Inc.
General & Plastic Surgery · 29d
Cleared May 31, 2001
ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145
K010898
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 66d
Cleared Apr 20, 2001
SONOTOME ULTRASONIC ASPIRATOR TIPS
K010637
Synergetics, Inc.
General & Plastic Surgery · 46d
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 Oct 10, 2000
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4
K000927
Misonix, Inc.
General & Plastic Surgery · 202d
Cleared Sep 26, 2000
OLYMPUS SONOSURG TROCAR XT3900 SYSTEM
K000095
The Olympus Optical Co.
General & Plastic Surgery · 257d
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 21, 1999
THE SOUNDVASER DISSECTION SYSTEM
K993868
Sound Surgical Technologies, LLC
General & Plastic Surgery · 36d
Cleared Dec 15, 1999
OMNISONICS ULTRASONIC PROBES
K993628
Omnisonics Medical Technologies
General & Plastic Surgery · 49d
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 Aug 12, 1999
SOUND VASER SYSTEM
K991791
Sound Surgical Technologies, LLC
General & Plastic Surgery · 79d
Cleared May 21, 1999
SONOTOME
K990572
Sonokinetics, 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 14, 1998
FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL
K983199
Fibra Sonics, Inc.
General & Plastic Surgery · 91d