FDA 510(k) General & Plastic Surgery Devices
About General & Plastic Surgery Devices
FDA 510(k) general and plastic surgery devices represent the largest 510(k) category with 18,104 submissions since 1976. The FDA review panel code is SU.
This panel covers a broad range of surgical equipment:
- Electrosurgical units (ESU) - monopolar and bipolar cutting and coagulation
- Surgical lasers - CO2, Nd:YAG, diode and excimer surgical lasers
- Laparoscopic instruments - trocars, graspers, staplers, clip appliers
- Wound care and closure - negative pressure therapy, staples, tissue adhesives
- Aesthetic devices - body contouring, skin resurfacing, fat reduction systems
18146
Total
18103
Cleared
114d
Avg days
1976
Since
1302 General & Plastic Surgery devices
Cleared
May 14, 2025
ETHICON 4000 60mm Compact Stapler (EC3D60C)
GDW
Staple, Implantable
55d
Cleared
May 14, 2025
MICROLET®NEXT 2 Lancing Device
QRL
Multiple Use Blood Lancet For Single Patient Use Only
58d
Cleared
May 14, 2025
Medical Picosecond ND: YAG Laser System (PZ-6)
GEX
Powered Laser Surgical Instrument
126d
Cleared
May 13, 2025
SP Endoscope, 0° (430600)
NAY
System, Surgical, Computer Controlled Instrument
60d
Cleared
May 13, 2025
Ulthera System (UC-1 Control Unit PRIME Model 2.1)
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
89d
Cleared
May 12, 2025
Medical Diode Laser Hair Removal System (MNLT-D1)
GEX
Powered Laser Surgical Instrument
87d
Cleared
May 12, 2025
AYON Body Contouring System (AYON SYSTEM)
QPB
System, Suction, Lipoplasty For Removal
132d
Cleared
May 09, 2025
Vigeon Laparoscopic Universal Smoke Evacuator (VG003)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
86d
Cleared
May 07, 2025
Cary
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
26d
Cleared
May 06, 2025
Alma Veil
GEX
Powered Laser Surgical Instrument
26d
Cleared
May 06, 2025
IPL Hair Removal Device (KCA511/KCA516/KCA522)
OHT
Light Based Over-the-counter Hair Removal
98d
Cleared
May 06, 2025
IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D)
OHT
Light Based Over-the-counter Hair Removal
221d
Cleared
May 05, 2025
Arthrex Synergy Vision Endoscopic Imaging System
GCJ
Laparoscope, General & Plastic Surgery
55d
Cleared
May 02, 2025
Anovo Instrument ARM Curved Scissors
QNM
Mountable Electromechanical Surgical System For Transluminal Approaches
28d
Cleared
May 02, 2025
Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel
FRO
Dressing, Wound, Drug
176d
Cleared
May 01, 2025
Wrinkle Treatment Device (JM1, JM2B)
OHS
Light Based Over The Counter Wrinkle Reduction
125d
Cleared
Apr 29, 2025
Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)
OAP
Laser, Comb, Hair
85d
Cleared
Apr 29, 2025
ExpressCore Biopsy Device
KNW
Instrument, Biopsy
132d
Cleared
Apr 28, 2025
Suture-TOOL System
NEW
Suture, Surgical, Absorbable, Polydioxanone
28d
Cleared
Apr 28, 2025
Diode laser hair removal machine (QDTM-02)
GEX
Powered Laser Surgical Instrument
215d
Cleared
Apr 26, 2025
AIRO Suction Unit (AIRO-01)
BTA
Pump, Portable, Aspiration (manual Or Powered)
15d
Cleared
Apr 25, 2025
PAL 7020 Console
QPB
System, Suction, Lipoplasty For Removal
116d
Cleared
Apr 25, 2025
RFMagik Lite
GEI
Electrosurgical, Cutting & Coagulation & Accessories
248d
Cleared
Apr 24, 2025
Diode laser system (Night Universe
GEX
Powered Laser Surgical Instrument
90d
Cleared
Apr 24, 2025
CO2 Laser System (CO2 Laser SST-L23)
GEX
Powered Laser Surgical Instrument
92d
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