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
1302 General & Plastic Surgery devices
Cleared
Apr 24, 2025
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
KNW
Instrument, Biopsy
125d
Cleared
Apr 24, 2025
da Vinci SP Surgical System (SP1098)
NAY
System, Surgical, Computer Controlled Instrument
143d
Cleared
Apr 24, 2025
MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs
LCJ
Tissue Expander And Accessories
211d
Cleared
Apr 23, 2025
Parietene™ Macroporous Mesh (PPM5050 )
FTL
Mesh, Surgical, Polymeric
30d
Cleared
Apr 21, 2025
Spectricept Skin and Wound Cleanser
FRO
Dressing, Wound, Drug
125d
Cleared
Apr 18, 2025
handLITE (TN19S)
ONE
Powered Light Based Non-laser Surgical Instrument
81d
Cleared
Apr 17, 2025
FLUOBEAM LX Imaging System (FBLX)
QDG
Parathyroid Autofluorescence Imaging Device
58d
Cleared
Apr 16, 2025
Stellar M22
GEX
Powered Laser Surgical Instrument
30d
Cleared
Apr 16, 2025
HEBE (NP0000763)
PBX
Massager, Vacuum, Radio Frequency Induced Heat
303d
Cleared
Apr 15, 2025
OptaBlate Radiofrequency (RF) Generator System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
69d
Cleared
Apr 15, 2025
Préime DermaFacial Collagen+
PBX
Massager, Vacuum, Radio Frequency Induced Heat
200d
Cleared
Apr 15, 2025
Skin Clinic Nitro Clear Wart Remover
GEH
Unit, Cryosurgical, Accessories
202d
Cleared
Apr 15, 2025
Electro Lube NXT
GEI
Electrosurgical, Cutting & Coagulation & Accessories
214d
Cleared
Apr 14, 2025
AVAVA™ Skin Treatment System
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
61d
Cleared
Apr 14, 2025
Elfor-L
DPW
Flowmeter, Blood, Cardiovascular
119d
Cleared
Apr 11, 2025
Alma Harmony
GEX
Powered Laser Surgical Instrument
196d
Cleared
Apr 09, 2025
Bard Soft Mesh
FTL
Mesh, Surgical, Polymeric
85d
Cleared
Apr 08, 2025
NPseal
OKO
Negative Pressure Wound Therapy Non-powered Suction Apparatus
29d
Cleared
Apr 08, 2025
Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)
OHS
Light Based Over The Counter Wrinkle Reduction
259d
Cleared
Apr 07, 2025
Ultraviolet Phototherapy Device
FTC
Light, Ultraviolet, Dermatological
52d
Cleared
Apr 07, 2025
E-PEN (E-PEN)
QAI
Powered Microneedle Device
189d
Cleared
Apr 07, 2025
LED Therapy Mask (MN1, M226)
OHS
Light Based Over The Counter Wrinkle Reduction
238d
Cleared
Apr 04, 2025
Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
GEX
Powered Laser Surgical Instrument
30d
Cleared
Apr 04, 2025
LED Light Therapy Mask (RT01)
OLP
Over-the-counter Powered Light Based Laser For Acne
263d
Cleared
Apr 02, 2025
VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
261d
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