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
1314 General & Plastic Surgery devices
Cleared
Oct 11, 2024
Accure Laser System
GEX
Powered Laser Surgical Instrument
91d
Cleared
Oct 11, 2024
LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
OHS
Light Based Over The Counter Wrinkle Reduction
106d
Cleared
Oct 11, 2024
PBM Hair Therapy Cap
OAP
Laser, Comb, Hair
234d
Cleared
Oct 11, 2024
Monotime and Optime R
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
378d
Not Cleared
Oct 11, 2024
Versius Surgical System
SCV
Modular Electromechanical Surgical System
325d
Cleared
Oct 10, 2024
Lasya-Trinity
GEX
Powered Laser Surgical Instrument
99d
Cleared
Oct 10, 2024
Youlaser PRIME
GEX
Powered Laser Surgical Instrument
171d
Cleared
Oct 09, 2024
TRAP EASY
KNW
Instrument, Biopsy
90d
Cleared
Oct 09, 2024
SER Pen Carain MicroSystem (MP1209SP)
QAI
Powered Microneedle Device
148d
Cleared
Oct 09, 2024
eMVFit (MVF-10M)
PBX
Massager, Vacuum, Radio Frequency Induced Heat
181d
Cleared
Oct 09, 2024
MEDIYAG
GEX
Powered Laser Surgical Instrument
467d
Cleared
Oct 07, 2024
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
FRO
Dressing, Wound, Drug
230d
Cleared
Oct 04, 2024
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series)
GDW
Staple, Implantable
28d
Cleared
Oct 04, 2024
TroCare TroKit Laparoscope Lens Wiper (CP000626)
GCJ
Laparoscope, General & Plastic Surgery
105d
Cleared
Oct 04, 2024
Bladeless Trocar
GCJ
Laparoscope, General & Plastic Surgery
170d
Cleared
Oct 04, 2024
Electroporation System (N3000)
OAB
Low Energy Direct Current Thermal Ablation System
240d
Cleared
Oct 02, 2024
Anovo Surgical System (model 6N)
QNM
Mountable Electromechanical Surgical System For Transluminal Approaches
93d
Cleared
Sep 27, 2024
Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938
NEW
Suture, Surgical, Absorbable, Polydioxanone
29d
Cleared
Sep 27, 2024
ACTIVO
GEX
Powered Laser Surgical Instrument
60d
Cleared
Sep 27, 2024
HIGHERDOSE Red and Infrared Light Mask (MK66-L)
OHS
Light Based Over The Counter Wrinkle Reduction
87d
Cleared
Sep 27, 2024
TearRepair Liquid Skin Protectant
KMF
Bandage, Liquid
88d
Cleared
Sep 26, 2024
Microwave Ablation Generator (KY-2000A, KY-2100A)
NEY
System, Ablation, Microwave And Accessories
94d
Cleared
Sep 26, 2024
MOLLI 2 System
NEU
Marker, Radiographic, Implantable
272d
Cleared
Sep 25, 2024
Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
61d
Cleared
Sep 25, 2024
Diode Laser Hair Removal System
GEX
Powered Laser Surgical Instrument
90d
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