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
Dec 01, 2004
HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
56d
Cleared
Sep 29, 2004
SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM
Integra Neurosciences, Ltd.
General & Plastic Surgery
37d
Cleared
Sep 08, 2004
SONOSURG ULTRASONIC SURGICAL SYSTEM
Aomori Olympus Co., Ltd.
General & Plastic Surgery
90d
Cleared
Dec 09, 2003
MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM
Misonix, Inc.
General & Plastic Surgery
98d
Cleared
Oct 03, 2003
SONOSURG SYSTEM
The Olympus Optical Co.
General & Plastic Surgery
92d
Cleared
Sep 23, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
Olympus Optical Co., Ltd.
General & Plastic Surgery
152d
Cleared
Feb 12, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
The Olympus Optical Co.
General & Plastic Surgery
243d
Cleared
Sep 10, 2002
AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM
Axya Medical, Inc.
General & Plastic Surgery
90d
Cleared
Aug 23, 2002
ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
Synergetics, Inc.
General & Plastic Surgery
213d
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
Jul 27, 2001
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5
Misonix, Inc.
General & Plastic Surgery
29d
Cleared
May 31, 2001
ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
66d
Cleared
Apr 20, 2001
SONOTOME ULTRASONIC ASPIRATOR TIPS
Synergetics, Inc.
General & Plastic Surgery
46d
Cleared
Dec 15, 2000
ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
88d
Cleared
Oct 10, 2000
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4
Misonix, Inc.
General & Plastic Surgery
202d
Cleared
Sep 26, 2000
OLYMPUS SONOSURG TROCAR XT3900 SYSTEM
The Olympus Optical Co.
General & Plastic Surgery
257d
Cleared
Mar 17, 2000
ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
88d
Cleared
Dec 21, 1999
THE SOUNDVASER DISSECTION SYSTEM
Sound Surgical Technologies, LLC
General & Plastic Surgery
36d
Cleared
Dec 15, 1999
OMNISONICS ULTRASONIC PROBES
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
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
87d
Cleared
Aug 12, 1999
SOUND VASER SYSTEM
Sound Surgical Technologies, LLC
General & Plastic Surgery
79d
Cleared
May 21, 1999
SONOTOME
Sonokinetics, Inc.
General & Plastic Surgery
87d
Cleared
Mar 12, 1999
ULTRACISION HARMONIC SCALPEL HAND PIECE
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery
29d
Cleared
Dec 14, 1998
FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL
Fibra Sonics, Inc.
General & Plastic Surgery
91d