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
18201
Total
18157
Cleared
138d
Avg (2y)
1976
Since
3952 General & Plastic Surgery devices
Cleared
Apr 15, 2022
mJOULE System and Accessories
GEX
Powered Laser Surgical Instrument
189d
Cleared
Apr 13, 2022
MCL 31 Dermablate System
GEX
Powered Laser Surgical Instrument
406d
Cleared
Apr 12, 2022
LED Therapy Device (Planar LED/Planar LED mini)
GEX
Powered Laser Surgical Instrument
90d
Cleared
Apr 12, 2022
Finexel
GEX
Powered Laser Surgical Instrument
155d
Cleared
Apr 11, 2022
Cellvizio 100 series system with confocal Miniprobes
OWN
Confocal Optical Imaging
52d
Cleared
Apr 11, 2022
Intense Pulsed Light (IPL) System
OHT
Light Based Over-the-counter Hair Removal
213d
Cleared
Apr 08, 2022
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
GAG
Stapler, Surgical
142d
Cleared
Apr 08, 2022
SCOUT BX Delivery System
NEU
Marker, Radiographic, Implantable
210d
Cleared
Apr 07, 2022
Green OR Reprocessed Aquamantys Bipolar Sealer
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
350d
Cleared
Apr 06, 2022
Plasmage System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
616d
Cleared
Apr 05, 2022
Accu-Chek Safe-T-Pro Uno Lancing Device
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
56d
Cleared
Apr 02, 2022
Trinity Plus Wrinkle Reducer
OHS
Light Based Over The Counter Wrinkle Reduction
199d
Cleared
Mar 31, 2022
TargetCool
GEH
Unit, Cryosurgical, Accessories
23d
Cleared
Mar 31, 2022
Golnit Nylon Monofilament Suture
GAR
Suture, Nonabsorbable, Synthetic, Polyamide
202d
Cleared
Mar 30, 2022
BD Trek Powered Bone Biopsy System
KNW
Instrument, Biopsy
106d
Cleared
Mar 30, 2022
EON
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
302d
Cleared
Mar 28, 2022
Hand-held IPL device(JOVS Graphene Hair Removal Device)
OHT
Light Based Over-the-counter Hair Removal
88d
Cleared
Mar 24, 2022
Erchonia Zerona Z-Bed
OLI
Fat Reducing Low Level Laser
29d
Cleared
Mar 24, 2022
AviClear Laser System
GEX
Powered Laser Surgical Instrument
148d
Cleared
Mar 23, 2022
Project E Beauty LED Light Therapy Mask (Model: PE730)
OHS
Light Based Over The Counter Wrinkle Reduction
84d
Cleared
Mar 23, 2022
ArthroFree Wireless Surgical Camera System
GCJ
Laparoscope, General & Plastic Surgery
103d
Cleared
Mar 23, 2022
BD Surgiphor Antimicrobial Irrigation System
FQH
Lavage, Jet
128d
Cleared
Mar 23, 2022
LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing
FRO
Dressing, Wound, Drug
378d
Cleared
Mar 22, 2022
Shani Darden LED light therapy mask
OLP
Over-the-counter Powered Light Based Laser For Acne
83d
Cleared
Mar 22, 2022
PLEXR PLUS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
379d
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