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
1299 General & Plastic Surgery devices
Cleared
Jul 11, 2025
KALA Therapy Wand (Model: KALA-03)
OHS
Light Based Over The Counter Wrinkle Reduction
120d
Cleared
Jul 11, 2025
Disposable Biopsy Needle
KNW
Instrument, Biopsy
266d
Cleared
Jul 10, 2025
Marquee™ Disposable Core Biopsy Instrument and Instrument Kit
KNW
Instrument, Biopsy
184d
Cleared
Jul 08, 2025
Anovo Surgical System (Model 6Ne)
QNM
Mountable Electromechanical Surgical System For Transluminal Approaches
29d
Cleared
Jul 08, 2025
DENSITY
GEI
Electrosurgical, Cutting & Coagulation & Accessories
179d
Cleared
Jul 03, 2025
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips
FZP
Clip, Implantable
90d
Cleared
Jul 03, 2025
Pastelle
GEX
Powered Laser Surgical Instrument
163d
Cleared
Jul 03, 2025
IPL Treatment Device (MDSQMC-01)
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
276d
Cleared
Jul 02, 2025
8 mm Assist Cannula
GCJ
Laparoscope, General & Plastic Surgery
49d
Cleared
Jul 02, 2025
SurgiLight 1470 Diode Laser System (Model:Halo)
GEX
Powered Laser Surgical Instrument
90d
Cleared
Jul 02, 2025
Fiber Laser Treatment Systems (HS-232,HS-233)
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
90d
Cleared
Jul 02, 2025
CS-Pro MED
PZL
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
110d
Cleared
Jul 02, 2025
AuroLase® System
GEX
Powered Laser Surgical Instrument
215d
Cleared
Jul 02, 2025
Boehringer Laboratories Liver Retractor
GCJ
Laparoscope, General & Plastic Surgery
244d
Cleared
Jul 01, 2025
Endoscopic Camera System
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
158d
Cleared
Jul 01, 2025
droplet® personal lancets
QRK
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
179d
Cleared
Jun 30, 2025
Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
OHT
Light Based Over-the-counter Hair Removal
90d
Cleared
Jun 27, 2025
Diode laser device (RF3120-BI)
GEX
Powered Laser Surgical Instrument
58d
Cleared
Jun 27, 2025
Maestro System (REF100)
QZB
Software Controlled Endoscope And Instrument Holder
88d
Cleared
Jun 27, 2025
Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
OMP
Negative Pressure Wound Therapy Powered Suction Pump
270d
Cleared
Jun 26, 2025
safety lancet
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
24d
Cleared
Jun 26, 2025
Optimas MAX System
GEX
Powered Laser Surgical Instrument
29d
Cleared
Jun 26, 2025
Lap.Ox™ Laparoscopic Tissue Oximeter
MUD
Oximeter, Tissue Saturation
125d
Cleared
Jun 25, 2025
CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)
OHS
Light Based Over The Counter Wrinkle Reduction
86d
Cleared
Jun 25, 2025
GeniPhys Collymer Self-Assembling Scaffold
KGN
Wound Dressing With Animal-derived Material(s)
140d
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