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
1292 General & Plastic Surgery devices
Cleared
Nov 25, 2025
Eva Scalp Cooling System
PMC
Scalp Cooling System
125d
Cleared
Nov 24, 2025
Thulium Fiber Laser System (TFL-A)
GEX
Powered Laser Surgical Instrument
83d
Cleared
Nov 24, 2025
Holmium Laser System (Potent HP90)
GEX
Powered Laser Surgical Instrument
83d
Cleared
Nov 24, 2025
F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
89d
Cleared
Nov 22, 2025
KARL STORZ Cholangiography Set
GCJ
Laparoscope, General & Plastic Surgery
239d
Cleared
Nov 21, 2025
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
OMP
Negative Pressure Wound Therapy Powered Suction Pump
267d
Cleared
Nov 20, 2025
CuRAS hybrid
GEX
Powered Laser Surgical Instrument
56d
Cleared
Nov 20, 2025
Laser Fiber (PT-OF-A-S)
GEX
Powered Laser Surgical Instrument
62d
Cleared
Nov 20, 2025
Disposable Polymer Ligation Clips
FZP
Clip, Implantable
261d
Cleared
Nov 20, 2025
Nuvis® Wireless HD Camera System (Nuvis-2K)
GCJ
Laparoscope, General & Plastic Surgery
447d
Cleared
Nov 19, 2025
LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)
OHS
Light Based Over The Counter Wrinkle Reduction
57d
Cleared
Nov 19, 2025
IPL Hair Removal Device (SYL001AZ, SYL002AZ)
OHT
Light Based Over-the-counter Hair Removal
58d
Cleared
Nov 19, 2025
Microcurrent Facial Device (CEC101, EEI101)
OHS
Light Based Over The Counter Wrinkle Reduction
90d
Cleared
Nov 19, 2025
LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
FRO
Dressing, Wound, Drug
260d
Cleared
Nov 17, 2025
TS-RF Generator (STS10)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
179d
Cleared
Nov 14, 2025
IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)
OHT
Light Based Over-the-counter Hair Removal
87d
Cleared
Nov 13, 2025
LED Beauty Mask (RLBXX)
OHS
Light Based Over The Counter Wrinkle Reduction
112d
Cleared
Nov 12, 2025
XSTAT P15
PGZ
Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
44d
Cleared
Nov 12, 2025
VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700)
OWN
Confocal Optical Imaging
196d
Cleared
Nov 12, 2025
PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
NEW
Suture, Surgical, Absorbable, Polydioxanone
328d
Cleared
Nov 10, 2025
Symani Surgical System
SAQ
Electromechanical System For Open Microsurgery
110d
Cleared
Nov 07, 2025
Medical Diode Laser Systems (VeinCure)
GEX
Powered Laser Surgical Instrument
85d
Cleared
Nov 07, 2025
CO2 Laser Therapy System (K106)
GEX
Powered Laser Surgical Instrument
88d
Cleared
Nov 06, 2025
Venus Nova (FP-2001)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
59d
Cleared
Nov 06, 2025
Q-Switched Nd:Yag laser (K690)
GEX
Powered Laser Surgical Instrument
87d
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