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
1328 General & Plastic Surgery devices
Cleared
Apr 18, 2023
SofWave System
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
25d
Cleared
Apr 13, 2023
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
58d
Cleared
Apr 11, 2023
L12 LED Light Source with AIM
OWN
Confocal Optical Imaging
25d
Cleared
Apr 10, 2023
IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
OHT
Light Based Over-the-counter Hair Removal
83d
Cleared
Apr 07, 2023
Peri-Guard and Supple Peri-Guard
FTM
Mesh, Surgical
190d
Cleared
Apr 05, 2023
CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)
OAP
Laser, Comb, Hair
57d
Cleared
Apr 05, 2023
Da Vinci SP Surgical System (SP1098)
NAY
System, Surgical, Computer Controlled Instrument
90d
Cleared
Apr 05, 2023
Antimicrobial Silicone PHMB Foam Wound Dressing
FRO
Dressing, Wound, Drug
159d
Cleared
Apr 05, 2023
FAQ 101
PAY
Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction
271d
Cleared
Mar 31, 2023
1788 4K Camera System with Advanced Imaging Modality
GCJ
Laparoscope, General & Plastic Surgery
28d
Cleared
Mar 30, 2023
HOPKINS Telescopes
GCJ
Laparoscope, General & Plastic Surgery
90d
Cleared
Mar 28, 2023
ISOLIS Cryoprobe
GEH
Unit, Cryosurgical, Accessories
56d
Cleared
Mar 28, 2023
Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019
GEI
Electrosurgical, Cutting & Coagulation & Accessories
56d
Cleared
Mar 28, 2023
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
57d
Cleared
Mar 27, 2023
Solero Microwave Tissue Ablation (MTA) System and Accessories
NEY
System, Ablation, Microwave And Accessories
116d
Cleared
Mar 24, 2023
3 Series NeoLux
FTC
Light, Ultraviolet, Dermatological
39d
Cleared
Mar 23, 2023
ClosureFast™ Endovenous Radiofrequency Ablation Catheter
GEI
Electrosurgical, Cutting & Coagulation & Accessories
122d
Cleared
Mar 22, 2023
HF Surgery Generator 400KHZ
GEI
Electrosurgical, Cutting & Coagulation & Accessories
57d
Cleared
Mar 16, 2023
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
NAY
System, Surgical, Computer Controlled Instrument
177d
Cleared
Mar 15, 2023
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
OHS
Light Based Over The Counter Wrinkle Reduction
57d
Cleared
Mar 14, 2023
SofWave System
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
70d
Cleared
Mar 09, 2023
LED Lip Perfector, model: ZC-05
ILY
Lamp, Infrared, Therapeutic Heating
93d
Cleared
Mar 07, 2023
Solero Microwave Tissue Ablation (MTA) System and Accessories
NEY
System, Ablation, Microwave And Accessories
251d
Cleared
Mar 01, 2023
Alma Harmony
GEX
Powered Laser Surgical Instrument
26d
Cleared
Feb 28, 2023
IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD
OHT
Light Based Over-the-counter Hair Removal
85d
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