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
1296 General & Plastic Surgery devices
Cleared
Aug 01, 2025
Self-Forming Magnet (Flexagon Plus OTOLoc)
SAH
Magnetic Compression Anastomosis System
158d
Cleared
Jul 31, 2025
eCO2 3D
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
212d
Cleared
Jul 30, 2025
Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)
GEX
Powered Laser Surgical Instrument
113d
Cleared
Jul 29, 2025
da Vinci Surgical System, IS5000
NAY
System, Surgical, Computer Controlled Instrument
165d
Cleared
Jul 25, 2025
InbellaMAX System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
10d
Cleared
Jul 25, 2025
Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
GEX
Powered Laser Surgical Instrument
86d
Cleared
Jul 24, 2025
SPY Laparoscope
GCJ
Laparoscope, General & Plastic Surgery
27d
Cleared
Jul 24, 2025
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
OHT
Light Based Over-the-counter Hair Removal
27d
Cleared
Jul 24, 2025
Onflex™ Mesh
FTL
Mesh, Surgical, Polymeric
29d
Cleared
Jul 24, 2025
Confocal Microprobe Imaging System (BrightP980)
OWN
Confocal Optical Imaging
234d
Cleared
Jul 23, 2025
MammoSTAR Biopsy Site Identifier
NEU
Marker, Radiographic, Implantable
47d
Cleared
Jul 23, 2025
Da Vinci Surgical System (IS5000)
NAY
System, Surgical, Computer Controlled Instrument
96d
Cleared
Jul 22, 2025
LymphaTech Mobile 3D Measuring Tool
SFG
Camera, Surgical, Measurement
90d
Cleared
Jul 22, 2025
Disposable Biopsy Needle
KNW
Instrument, Biopsy
207d
Cleared
Jul 22, 2025
Granudacyn® Wound Irrigation Solution
FRO
Dressing, Wound, Drug
263d
Cleared
Jul 17, 2025
Masimo O3 Regional Oximeter
MUD
Oximeter, Tissue Saturation
267d
Cleared
Jul 16, 2025
Marigen Wound Extra
KGN
Wound Dressing With Animal-derived Material(s)
30d
Cleared
Jul 16, 2025
da Vinci Surgical System (IS5000)
NAY
System, Surgical, Computer Controlled Instrument
89d
Cleared
Jul 15, 2025
Kerecis SurgiBind (50241)
OXH
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
29d
Cleared
Jul 14, 2025
Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
OHT
Light Based Over-the-counter Hair Removal
89d
Cleared
Jul 14, 2025
Leonardo Duster
GEX
Powered Laser Surgical Instrument
144d
Cleared
Jul 11, 2025
AEON™ Endoscopic Powered Stapler
GAG
Stapler, Surgical
58d
Cleared
Jul 11, 2025
AviClear Laser System
GEX
Powered Laser Surgical Instrument
88d
Cleared
Jul 11, 2025
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
OHT
Light Based Over-the-counter Hair Removal
105d
Cleared
Jul 11, 2025
Disposable Trocars
GCJ
Laparoscope, General & Plastic Surgery
115d
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