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
1321 General & Plastic Surgery devices
Cleared
Apr 17, 2024
Carilex VT¿200-i NX
OMP
Negative Pressure Wound Therapy Powered Suction Pump
317d
Cleared
Apr 16, 2024
ReBorn (1050nm)
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
123d
Cleared
Apr 16, 2024
Co2 Laser System, Models: PureLase And VanLase
GEX
Powered Laser Surgical Instrument
273d
Cleared
Apr 15, 2024
Ez Catch Auto
GCJ
Laparoscope, General & Plastic Surgery
81d
Cleared
Apr 11, 2024
TitanPico Laser Workstation (PICO-450)
GEX
Powered Laser Surgical Instrument
139d
Cleared
Apr 10, 2024
Face Patches (MT-12MA, MT-12MC)
OHS
Light Based Over The Counter Wrinkle Reduction
89d
Cleared
Apr 10, 2024
NIRVANA
GEX
Powered Laser Surgical Instrument
110d
Cleared
Apr 09, 2024
GalaFLEX LITE Scaffold
OOD
Surgical Film
113d
Cleared
Apr 09, 2024
Disposable Trocars
GCJ
Laparoscope, General & Plastic Surgery
193d
Cleared
Apr 05, 2024
Wrinkle Treatment Device (JM2)
OHS
Light Based Over The Counter Wrinkle Reduction
59d
Not Cleared
Apr 05, 2024
Symani Surgical System
SAQ
Electromechanical System For Open Microsurgery
346d
Cleared
Apr 04, 2024
Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
OHT
Light Based Over-the-counter Hair Removal
28d
Cleared
Apr 03, 2024
IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)
OHT
Light Based Over-the-counter Hair Removal
62d
Cleared
Apr 02, 2024
SnapshotNIR model KD205
MUD
Oximeter, Tissue Saturation
29d
Cleared
Apr 01, 2024
ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm
GCJ
Laparoscope, General & Plastic Surgery
26d
Cleared
Mar 29, 2024
SmoothSkin Pure Unplugged (SSB3)
OHT
Light Based Over-the-counter Hair Removal
28d
Cleared
Mar 28, 2024
Emprint Ablation System with Thermosphere Technology (Overall System Name)
NEY
System, Ablation, Microwave And Accessories
115d
Cleared
Mar 28, 2024
BTL-785S
GEI
Electrosurgical, Cutting & Coagulation & Accessories
140d
Cleared
Mar 27, 2024
Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 )
NEW
Suture, Surgical, Absorbable, Polydioxanone
48d
Cleared
Mar 27, 2024
LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing
FRO
Dressing, Wound, Drug
510d
Not Cleared
Mar 27, 2024
Medline ART Skin Harvesting System
QYK
Semi-automated Autologous Skin Graft Harvesting And Application Device
890d
Cleared
Mar 26, 2024
PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)
FRO
Dressing, Wound, Drug
181d
Cleared
Mar 22, 2024
Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in)
FRO
Dressing, Wound, Drug
266d
Cleared
Mar 21, 2024
Medical Diode Laser (Model: L2)
GEX
Powered Laser Surgical Instrument
58d
Cleared
Mar 21, 2024
RedDrop ONE (One)
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
90d
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