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 Integra LifeSciences Corporation, Stryker Corporation and Misonix, Inc..

157
Total
157
Cleared
123d
Avg days
1980
Since
Declining activity - 5 submissions in the last 2 years vs 11 in the prior period
Review times increasing: avg 168d recently vs 122d historically

FDA 510(k) Cleared Instrument, Ultrasonic Surgical Devices (Product Code LFL)

157 devices
1–24 of 157
Cleared Oct 08, 2025
CUSA® Clarity Ultrasonic Surgical Aspirator System
K251162
Integra LifeSciences Corporation
General & Plastic Surgery · 176d
Cleared Jun 18, 2025
SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10)
K242894
Shanghai Saints Sages Surgical Co., Ltd.
General & Plastic Surgery · 268d
Cleared Mar 24, 2025
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K243930
Stryker Instruments
General & Plastic Surgery · 94d
Cleared Nov 18, 2024
Tenex 2nd Generation System
K241700
Trice Medical, Inc.
General & Plastic Surgery · 158d
Cleared Jul 11, 2024
CUSA® Clarity Ultrasonic Surgical Aspirator System
K240493
Integra LifeSciences Corporation
Obstetrics & Gynecology · 142d
Cleared Jun 18, 2024
Ultrasonic Surgical System
K233036
Hunan Handlike Minimally Invasive Surgery Co., Ltd.
General & Plastic Surgery · 267d
Cleared Jul 11, 2023
CUSA Clarity Ultrasonic Surgical Aspirator System
K230427
Integra LifeSciences Corporation
General & Plastic Surgery · 144d
Cleared Jun 23, 2023
neXus Ultrasonic Surgical Aspirator System
K231117
Misonix, LLC, A Bioventus Company
General & Plastic Surgery · 64d
Cleared Feb 28, 2023
HARMONIC 700 Shears
K221790
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 252d
Cleared Feb 16, 2023
Sonopet 1Q 3 7cm 1Q Large
K223770
Stryker Corporation
General & Plastic Surgery · 63d
Cleared Dec 15, 2022
LOTUS Series 4 Enhanced Shears, LOTUS Series 5
K221102
Sra Developments, Ltd.
General & Plastic Surgery · 245d
Cleared Sep 30, 2022
Ultrasonic Surgical System
K210567
Miconvey Technologies Co., Ltd.
General & Plastic Surgery · 581d
Cleared Aug 22, 2022
CUSA Clarity Ultrasonic Surgical Aspirator System
K221835
Integra LifeSciences Corporation
General & Plastic Surgery · 60d
Cleared Jul 28, 2022
neXus Ultrasonic Surgical Aspirator System
K221235
Misonix, Inc.
General & Plastic Surgery · 90d
Cleared Jul 18, 2022
Ultrasonic Scalpel System
K212614
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
General & Plastic Surgery · 334d
Cleared Jul 15, 2022
CUSA Clarity Ultrasonic Surgical Aspirator System
K221763
Integra LifeSciences Corporation
General & Plastic Surgery · 28d
Cleared Mar 08, 2022
Oclet TDS 1000
K212049
Tendonova Corporation
General & Plastic Surgery · 251d
Cleared Feb 03, 2022
Sonopet iQ Ultrasonic Aspirator System
K213824
Stryker Corporation
General & Plastic Surgery · 57d
Cleared Dec 13, 2021
neXus Ultrasonic Surgical Aspirator System
K212060
Misonix, Inc.
General & Plastic Surgery · 165d
Cleared Nov 15, 2021
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
K212301
Covidien, LLC
General & Plastic Surgery · 115d
Cleared Sep 27, 2021
Ultrasonic Surgical Aspirator System, Model: XD880B
K212750
Smtp Technology Co., Ltd.
General & Plastic Surgery · 28d
Cleared Aug 04, 2021
Ultrasonic Bipolar Generator USG-410 with accessories
K211838
Olympus Medical Systems Corporation
General & Plastic Surgery · 51d
Cleared May 21, 2021
Ultrasonic Surgical Aspirator System
K202299
Smtp Technology Co., Ltd.
General & Plastic Surgery · 281d
Cleared May 21, 2021
Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
K211273
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 24d

About Product Code LFL - Regulatory Context

510(k) Submission Activity

157 total 510(k) submissions under product code LFL since 1980, with 157 receiving FDA clearance (average review time: 123 days).

Submission volume has declined in recent years - 5 submissions in the last 24 months compared to 11 in the prior period.

FDA 510(k) Review Time - LFL Product Code

Recent submissions under LFL have taken an average of 168 days to reach a decision - up from 122 days historically. Manufacturers should account for longer review timelines in current project planning.

LFL devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →