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
7582 General & Plastic Surgery devices
Cleared
Nov 28, 2022
da Vinci E-200 Electrosurgical Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
60d
Cleared
Nov 28, 2022
T-Line Hernia Mesh
FTL
Mesh, Surgical, Polymeric
181d
Cleared
Nov 23, 2022
TempSure System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
28d
Cleared
Nov 23, 2022
LDE4 Lancing Device
QRL
Multiple Use Blood Lancet For Single Patient Use Only
82d
Cleared
Nov 23, 2022
Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
154d
Cleared
Nov 22, 2022
da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
NAY
System, Surgical, Computer Controlled Instrument
53d
Cleared
Nov 22, 2022
Renasys Edge (66803126)
OMP
Negative Pressure Wound Therapy Powered Suction Pump
54d
Cleared
Nov 22, 2022
LED Light Therapy Mask (model: MK66R-B)
OHS
Light Based Over The Counter Wrinkle Reduction
140d
Cleared
Nov 22, 2022
Canady Flex RoboWrist
GCJ
Laparoscope, General & Plastic Surgery
449d
Cleared
Nov 21, 2022
Miro3D Wound Matrix
KGN
Wound Dressing With Animal-derived Material(s)
31d
Cleared
Nov 21, 2022
Disposable Sterile Lancet
QRL
Multiple Use Blood Lancet For Single Patient Use Only
118d
Cleared
Nov 21, 2022
SR-1 Skin Treatment System
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
203d
Cleared
Nov 18, 2022
MANTA Laser
GEX
Powered Laser Surgical Instrument
72d
Cleared
Nov 18, 2022
Facet Blood Lancets
QRL
Multiple Use Blood Lancet For Single Patient Use Only
88d
Cleared
Nov 18, 2022
Hair Growth Device
OAP
Laser, Comb, Hair
94d
Cleared
Nov 18, 2022
SiOxD Wound Matrix
QSZ
Absorbable Synthetic Wound Dressing
119d
Cleared
Nov 17, 2022
easy Claire
OHS
Light Based Over The Counter Wrinkle Reduction
24d
Cleared
Nov 17, 2022
Alexandrite and Nd:YAG Laser models CANLASE and TORLASE
GEX
Powered Laser Surgical Instrument
72d
Cleared
Nov 17, 2022
IPL Hair Removal Device
OHT
Light Based Over-the-counter Hair Removal
80d
Cleared
Nov 17, 2022
Accure Laser
GEX
Powered Laser Surgical Instrument
122d
Cleared
Nov 17, 2022
C.C. LIFE 21
PBX
Massager, Vacuum, Radio Frequency Induced Heat
412d
Cleared
Nov 17, 2022
Supra Non-Stick Bipolar Forceps
GEI
Electrosurgical, Cutting & Coagulation & Accessories
421d
Cleared
Nov 17, 2022
TFX-LT2000 Therapy Light
PDZ
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
570d
Cleared
Nov 16, 2022
Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)
OAP
Laser, Comb, Hair
104d
Cleared
Nov 15, 2022
Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS
GEX
Powered Laser Surgical Instrument
50d
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