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
18368
Total
18322
Cleared
136d
Avg (2y)
1976
Since
18368 General & Plastic Surgery devices
Cleared
Nov 19, 2021
Leaf Smooth
OHT
Light Based Over-the-counter Hair Removal
86d
Cleared
Nov 19, 2021
Finebeam
GEX
Powered Laser Surgical Instrument
464d
Cleared
Nov 18, 2021
IPL Hair Removal, Model: OBT-02
OHT
Light Based Over-the-counter Hair Removal
57d
Cleared
Nov 18, 2021
Dermalux Flex MD
OHS
Light Based Over The Counter Wrinkle Reduction
121d
Cleared
Nov 15, 2021
KARL STORZ ICG Imaging System
OWN
Confocal Optical Imaging
82d
Cleared
Nov 15, 2021
Darwin
GEX
Powered Laser Surgical Instrument
90d
Cleared
Nov 15, 2021
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
LFL
Instrument, Ultrasonic Surgical
115d
Cleared
Nov 15, 2021
SofWave System
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
187d
Cleared
Nov 10, 2021
Diode laser therapy system
GEX
Powered Laser Surgical Instrument
54d
Cleared
Nov 10, 2021
Reverso
GEI
Electrosurgical, Cutting & Coagulation & Accessories
127d
Cleared
Nov 09, 2021
BodySculp
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
105d
Cleared
Nov 09, 2021
Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories
GEX
Powered Laser Surgical Instrument
176d
Cleared
Nov 05, 2021
CoolSculpting Elite System
OOK
Dermal Cooling Pack/vacuum/massager
71d
Cleared
Nov 05, 2021
Resonic Rapid Acoustic Pulse Device
GEX
Powered Laser Surgical Instrument
88d
Cleared
Nov 05, 2021
SoftFix Balloon Trocar
GCJ
Laparoscope, General & Plastic Surgery
168d
Cleared
Nov 04, 2021
IPL Hair Removal Device, model: AI01
OHT
Light Based Over-the-counter Hair Removal
55d
Cleared
Nov 04, 2021
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)
GCJ
Laparoscope, General & Plastic Surgery
86d
Cleared
Nov 04, 2021
7 Series Phototherapy Device
FTC
Light, Ultraviolet, Dermatological
86d
Cleared
Oct 29, 2021
VersaWrap
FTM
Mesh, Surgical
31d
Cleared
Oct 29, 2021
TraumaGuard Intra-abdominal Pressure Sensing System
PHU
Intra-abdominal Pressure Monitoring Device
245d
Cleared
Oct 28, 2021
Disposable Monopolar Laparoscopic Tips and Reusable Handles
GEI
Electrosurgical, Cutting & Coagulation & Accessories
206d
Cleared
Oct 27, 2021
PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology
FTM
Mesh, Surgical
30d
Cleared
Oct 27, 2021
V.A.C.ULTA Negative Pressure Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
351d
Cleared
Oct 27, 2021
The Alma Opus System, Colibri Applicator and Tips
GEI
Electrosurgical, Cutting & Coagulation & Accessories
506d
Cleared
Oct 26, 2021
Medical Diode Laser Systems
GEX
Powered Laser Surgical Instrument
123d
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