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
Dec 19, 2025
MatriDerm pluS+ Bi-Layer
KGN
Wound Dressing With Animal-derived Material(s)
273d
Cleared
Dec 18, 2025
MOVIVA® Hybrid Ablation Probe
GEI
Electrosurgical, Cutting & Coagulation & Accessories
10d
Cleared
Dec 17, 2025
Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)
OHS
Light Based Over The Counter Wrinkle Reduction
90d
Cleared
Dec 17, 2025
ETHICON™ 4000 45mm Compact Stapler (EC3DT45C)
GDW
Staple, Implantable
111d
Cleared
Dec 16, 2025
TroClose 1200
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
28d
Cleared
Dec 16, 2025
Versius Surgical System (Versius Plus)
SCV
Modular Electromechanical Surgical System
162d
Cleared
Dec 15, 2025
da Vinci SP Surgical System (SP1098)
NAY
System, Surgical, Computer Controlled Instrument
112d
Cleared
Dec 15, 2025
Erchonia CLX (Model # CFL)
OLI
Fat Reducing Low Level Laser
123d
Cleared
Dec 15, 2025
MFUSE (MS001)
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
314d
Cleared
Dec 12, 2025
TRAUMAGEL® 2.0 Hemostatic Gel
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
24d
Cleared
Dec 12, 2025
Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
GEX
Powered Laser Surgical Instrument
105d
Cleared
Dec 12, 2025
EnCor EnCompass™ Breast Biopsy and Tissue Removal System
KNW
Instrument, Biopsy
109d
Cleared
Dec 12, 2025
VizMark Preloaded Tissue Marker Device (VM-0001)
NEU
Marker, Radiographic, Implantable
168d
Cleared
Dec 09, 2025
Lancing device (HH-XV-T)
QRL
Multiple Use Blood Lancet For Single Patient Use Only
15d
Cleared
Dec 09, 2025
Focused Cryotherapy System
GEH
Unit, Cryosurgical, Accessories
273d
Cleared
Dec 08, 2025
LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)
OHS
Light Based Over The Counter Wrinkle Reduction
81d
Cleared
Dec 05, 2025
Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
OHS
Light Based Over The Counter Wrinkle Reduction
150d
Cleared
Dec 03, 2025
Hugo™ RAS System
SCV
Modular Electromechanical Surgical System
268d
Cleared
Dec 02, 2025
da Vinci SP Surgical System (SP1098)
NAY
System, Surgical, Computer Controlled Instrument
154d
Cleared
Dec 01, 2025
Led Light Phototherapy Bed (Pro 450/ GY-680A)
OLI
Fat Reducing Low Level Laser
90d
Cleared
Nov 28, 2025
Dendrite Imaging System
QDG
Parathyroid Autofluorescence Imaging Device
60d
Cleared
Nov 28, 2025
Medical Diode Laser Systems (TR-B)
GEX
Powered Laser Surgical Instrument
98d
Cleared
Nov 25, 2025
BELLUS-Q
GEX
Powered Laser Surgical Instrument
56d
Cleared
Nov 25, 2025
IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)
OHT
Light Based Over-the-counter Hair Removal
57d
Cleared
Nov 25, 2025
LeafPure-Echo (LM-LPNdA)
GEX
Powered Laser Surgical Instrument
57d
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