FDA 510(k) General & Plastic Surgery Devices
FDA 510(k) General & Plastic Surgery Devices - Regulatory Overview
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
18256
Total
18211
Cleared
136d
Avg (2y)
1976
Since
7526 General & Plastic Surgery devices
Cleared
Apr 24, 2024
IPL Home Use Hair Removal Device (SJ15)
OHT
Light Based Over-the-counter Hair Removal
103d
Cleared
Apr 23, 2024
Dexcom G7 Continuous Glucose Monitoring System
QBJ
Integrated Continuous Glucose Monitoring System, Factory Calibrated
21d
Cleared
Apr 23, 2024
MeDioStar
GEX
Powered Laser Surgical Instrument
29d
Cleared
Apr 23, 2024
swiftPro™ System
NEY
System, Ablation, Microwave And Accessories
60d
Cleared
Apr 23, 2024
ReNew XR Handpiece, 25cm, with Reference Markings (3943M)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
116d
Cleared
Apr 23, 2024
BTL-499
GEI
Electrosurgical, Cutting & Coagulation & Accessories
140d
Cleared
Apr 23, 2024
mJOULE RF System and Accessories
GEI
Electrosurgical, Cutting & Coagulation & Accessories
574d
Cleared
Apr 19, 2024
Miro3D Fibers Wound Matrix
KGN
Wound Dressing With Animal-derived Material(s)
30d
Cleared
Apr 19, 2024
FAQ™ 201, FAQ™ 202
OHS
Light Based Over The Counter Wrinkle Reduction
72d
Cleared
Apr 19, 2024
Hemoblock_S (Prescription)
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
268d
Cleared
Apr 19, 2024
ReyaGel (RG03 - MTP gel 3mL)
KGN
Wound Dressing With Animal-derived Material(s)
269d
Cleared
Apr 18, 2024
Prospera Spectruum Negative Pressure Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
447d
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
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