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
1299 General & Plastic Surgery devices
Cleared
Jun 24, 2025
HyperSnap Surgical System (HSS)
SFE
Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
145d
Cleared
Jun 23, 2025
OPXION Optical Skin Viewer (OPXSV1-01F)
NQQ
System, Imaging, Optical Coherence Tomography (oct)
272d
Cleared
Jun 20, 2025
NovoSorb BTM
QSZ
Absorbable Synthetic Wound Dressing
29d
Cleared
Jun 20, 2025
Restrata Soft Tissue Reinforcement (STR)
OXF
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
60d
Cleared
Jun 20, 2025
LED LIGHT MASK (A093)
OHS
Light Based Over The Counter Wrinkle Reduction
88d
Cleared
Jun 20, 2025
LED Facial Mask
OHS
Light Based Over The Counter Wrinkle Reduction
179d
Cleared
Jun 20, 2025
HybridAPC probe
GEI
Electrosurgical, Cutting & Coagulation & Accessories
263d
Cleared
Jun 20, 2025
CollOvine™ Wound Dressing
KGN
Wound Dressing With Animal-derived Material(s)
267d
Cleared
Jun 19, 2025
Electrosurgical Pads
GEI
Electrosurgical, Cutting & Coagulation & Accessories
58d
Cleared
Jun 18, 2025
SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10)
LFL
Instrument, Ultrasonic Surgical
268d
Cleared
Jun 17, 2025
CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
OAP
Laser, Comb, Hair
76d
Cleared
Jun 15, 2025
IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29)
OHT
Light Based Over-the-counter Hair Removal
261d
Cleared
Jun 13, 2025
Vessel Sealer Curved (480522)
NAY
System, Surgical, Computer Controlled Instrument
99d
Cleared
Jun 13, 2025
MV Flow Aspiration Pump (MVFLOWPMP01)
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
200d
Cleared
Jun 12, 2025
Bard® Mesh
FTL
Mesh, Surgical, Polymeric
22d
Cleared
Jun 12, 2025
Medical Monitor (32HS710S)
GCJ
Laparoscope, General & Plastic Surgery
55d
Cleared
Jun 12, 2025
Q-Switched Nd:YAG Laser (SHE-LSP101-1)
GEX
Powered Laser Surgical Instrument
76d
Cleared
Jun 12, 2025
Fractional CO2 Laser Machine
GEX
Powered Laser Surgical Instrument
90d
Cleared
Jun 12, 2025
Deka Bluebeam
GEX
Powered Laser Surgical Instrument
195d
Cleared
Jun 11, 2025
Self-Forming Magnet (Flexagon)
SAH
Magnetic Compression Anastomosis System
215d
Cleared
Jun 11, 2025
da Vinci X Surgical System (IS4200)
NAY
System, Surgical, Computer Controlled Instrument
440d
Cleared
Jun 10, 2025
EndyMed PRO MAX
GEI
Electrosurgical, Cutting & Coagulation & Accessories
257d
Cleared
Jun 09, 2025
Bonvadis®
FRO
Dressing, Wound, Drug
60d
Cleared
Jun 09, 2025
LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
OHS
Light Based Over The Counter Wrinkle Reduction
82d
Cleared
Jun 09, 2025
CO2 Laser Machine (Lume)
GEX
Powered Laser Surgical Instrument
111d
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