FDA 510(k) General & Plastic Surgery Devices
FDA 510(k) General & Plastic Surgery Devices - Regulatory Overview
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
18368
Total
18322
Cleared
136d
Avg (2y)
1976
Since
18368 General & Plastic Surgery devices
Cleared
Jan 08, 2024
Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1
GEI
Electrosurgical, Cutting & Coagulation & Accessories
56d
Cleared
Jan 08, 2024
Air Gap Fiber
GEX
Powered Laser Surgical Instrument
178d
Cleared
Jan 05, 2024
IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG)
OHT
Light Based Over-the-counter Hair Removal
50d
Cleared
Jan 05, 2024
ENDOCOLLECT Specimen Retrieval Bag
GCJ
Laparoscope, General & Plastic Surgery
140d
Cleared
Jan 05, 2024
HS Fiber Sutures
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
256d
Cleared
Jan 05, 2024
Solon
GEX
Powered Laser Surgical Instrument
567d
Cleared
Jan 04, 2024
LED Eye mask (EY-20R, A20, EY-20N)
OHS
Light Based Over The Counter Wrinkle Reduction
59d
Cleared
Jan 04, 2024
Lancing System
QRK
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
154d
Cleared
Jan 04, 2024
LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing
FRO
Dressing, Wound, Drug
629d
Cleared
Jan 02, 2024
MOSAIC 3D (Surgical Laser)
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
60d
Cleared
Dec 22, 2023
Omnimax S3, Omnimax S4
GEX
Powered Laser Surgical Instrument
84d
Cleared
Dec 22, 2023
SofWave System
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
87d
Cleared
Dec 22, 2023
VIO System (V-1000)
QZN
Multi-photon Imaging
102d
Cleared
Dec 21, 2023
PICOSECOND Nd:YAG Laser System
GEX
Powered Laser Surgical Instrument
90d
Cleared
Dec 21, 2023
LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing
FRO
Dressing, Wound, Drug
413d
Cleared
Dec 20, 2023
SmoothSkin Pure Adapt (SSG3)
OHT
Light Based Over-the-counter Hair Removal
23d
Cleared
Dec 20, 2023
10THERMA
GEI
Electrosurgical, Cutting & Coagulation & Accessories
89d
Cleared
Dec 18, 2023
SiOxD Wound Matrix
QSZ
Absorbable Synthetic Wound Dressing
95d
Cleared
Dec 18, 2023
CuratOR EX3242-FD
GCJ
Laparoscope, General & Plastic Surgery
248d
Cleared
Dec 15, 2023
FLUOBEAM® LX Imaging System (FB-LX)
QDG
Parathyroid Autofluorescence Imaging Device
39d
Cleared
Dec 15, 2023
xeo+ Family
GEX
Powered Laser Surgical Instrument
78d
Cleared
Dec 15, 2023
IPL Hair Removal Device
OHT
Light Based Over-the-counter Hair Removal
86d
Cleared
Dec 14, 2023
Secret Pro
GEI
Electrosurgical, Cutting & Coagulation & Accessories
73d
Cleared
Dec 13, 2023
DT Controlled Phototherapy Equipment
FTC
Light, Ultraviolet, Dermatological
14d
Cleared
Dec 13, 2023
Radiant Renewal Skincare Wand (HD-15, HD-15A)
OHS
Light Based Over The Counter Wrinkle Reduction
89d
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