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
1294 General & Plastic Surgery devices
Cleared
Oct 16, 2025
ProZip Knotless Implant
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
27d
Cleared
Oct 16, 2025
CryoFreeze Wart and Skin Tag Remover
GEH
Unit, Cryosurgical, Accessories
28d
Cleared
Oct 16, 2025
Light Therapy Mask (1019055)
OHS
Light Based Over The Counter Wrinkle Reduction
105d
Cleared
Oct 16, 2025
Arthrex Synergy Vision Imaging System
GCJ
Laparoscope, General & Plastic Surgery
111d
Cleared
Oct 16, 2025
Coolfase
GEI
Electrosurgical, Cutting & Coagulation & Accessories
209d
Cleared
Oct 16, 2025
SurgiAid Collagen Wound Dressing (HA)
KGN
Wound Dressing With Animal-derived Material(s)
455d
Cleared
Oct 15, 2025
TargetCool-e
GEH
Unit, Cryosurgical, Accessories
15d
Cleared
Oct 15, 2025
InbellaMulti System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
77d
Cleared
Oct 15, 2025
V-soft Line™ Barbed Surgical Suture (Various)
NEW
Suture, Surgical, Absorbable, Polydioxanone
273d
Cleared
Oct 14, 2025
IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)
OHT
Light Based Over-the-counter Hair Removal
89d
Cleared
Oct 14, 2025
Lithoblast Single Use Holmium Laser Fibers
GEX
Powered Laser Surgical Instrument
214d
Cleared
Oct 14, 2025
Hemastyl(™) Wound Dressing
FRO
Dressing, Wound, Drug
271d
Cleared
Oct 12, 2025
GENEO X ELITE
PAY
Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction
439d
Cleared
Oct 10, 2025
Verruca-Freeze H Plus
GEH
Unit, Cryosurgical, Accessories
29d
Cleared
Oct 10, 2025
IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)
OHT
Light Based Over-the-counter Hair Removal
87d
Cleared
Oct 10, 2025
Collagen Wound Dressing
KGN
Wound Dressing With Animal-derived Material(s)
105d
Cleared
Oct 10, 2025
Tegaderm Post-Op Transparent Antimicrobial Dressing
FRO
Dressing, Wound, Drug
115d
Cleared
Oct 09, 2025
ORA Method LED Gua Sha (GS-04)
OHS
Light Based Over The Counter Wrinkle Reduction
79d
Cleared
Oct 08, 2025
The Botticelli (Model: Athena)
GEX
Powered Laser Surgical Instrument
128d
Cleared
Oct 08, 2025
CUSA® Clarity Ultrasonic Surgical Aspirator System
LFL
Instrument, Ultrasonic Surgical
176d
Cleared
Oct 07, 2025
deepLive (OSP12 + DMS)
NQQ
System, Imaging, Optical Coherence Tomography (oct)
29d
Cleared
Oct 07, 2025
Ultrasonic Bipolar Generator (USG-410)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
90d
Cleared
Oct 07, 2025
Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
215d
Cleared
Oct 03, 2025
PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso)
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
29d
Cleared
Oct 03, 2025
extriCARE® 1000 Negative Pressure Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
127d
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