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
1292 General & Plastic Surgery devices
Cleared
Mar 09, 2026
Medicell Mycosis Laser (MCML24004)
PDZ
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
89d
Cleared
Mar 09, 2026
NeoSculpt Plus
PBX
Massager, Vacuum, Radio Frequency Induced Heat
180d
Cleared
Mar 06, 2026
Holmium Laser Therapeutic Apparatus (HZ-A)
GEX
Powered Laser Surgical Instrument
86d
Cleared
Mar 04, 2026
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module
KNW
Instrument, Biopsy
28d
Cleared
Mar 04, 2026
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
OLP
Over-the-counter Powered Light Based Laser For Acne
90d
Cleared
Mar 04, 2026
Klär Lite (RCW-KL1000)
FTC
Light, Ultraviolet, Dermatological
90d
Cleared
Mar 03, 2026
CO2 Laser Treatment Machine (CFR3M1)
GEX
Powered Laser Surgical Instrument
85d
Cleared
Mar 03, 2026
LED Therapy Light (COB1400, HP1800PRO)
OHS
Light Based Over The Counter Wrinkle Reduction
89d
Cleared
Mar 02, 2026
Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)
NEY
System, Ablation, Microwave And Accessories
96d
Cleared
Mar 02, 2026
Microwave Ablation Device
NEY
System, Ablation, Microwave And Accessories
194d
Cleared
Mar 02, 2026
POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
207d
Cleared
Feb 27, 2026
Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)
GEX
Powered Laser Surgical Instrument
88d
Cleared
Feb 27, 2026
Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)
GEX
Powered Laser Surgical Instrument
88d
Cleared
Feb 27, 2026
C-Lant Port
GCJ
Laparoscope, General & Plastic Surgery
184d
Cleared
Feb 26, 2026
CAPRI
GEX
Powered Laser Surgical Instrument
58d
Cleared
Feb 26, 2026
KARL STORZ ICG Imaging System with RUBINA® Lens
OWN
Confocal Optical Imaging
59d
Cleared
Feb 26, 2026
Ganymede 2cm diameter (FG100300)
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
269d
Cleared
Feb 25, 2026
BD Surgiphor™ Antimicrobial Irrigation System (910110)
FQH
Lavage, Jet
75d
Cleared
Feb 24, 2026
XSense Cryoablation System with CryoProbes
GEH
Unit, Cryosurgical, Accessories
19d
Cleared
Feb 24, 2026
SP Electrocautery Device (SP20)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
26d
Cleared
Feb 24, 2026
Universal Seal (5-12 mm)
GCJ
Laparoscope, General & Plastic Surgery
74d
Cleared
Feb 24, 2026
Diode Laser Therapy Systems (WLA-02)
GEX
Powered Laser Surgical Instrument
190d
Cleared
Feb 24, 2026
Swift Ray 1
QJF
Autofluorescence Imaging Adjunct Tool For Wounds
270d
Cleared
Feb 23, 2026
IPL Hair Removal Device (Models: T31A, T32A)
OHT
Light Based Over-the-counter Hair Removal
94d
Cleared
Feb 23, 2026
Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402)
KGW
Ring (wound Protector), Drape Retention, Internal
102d
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