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
18288
Total
18243
Cleared
138d
Avg (2y)
1976
Since
13508 General & Plastic Surgery devices
Cleared
Apr 28, 2023
Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
OAP
Laser, Comb, Hair
126d
Cleared
Apr 27, 2023
Braun Skin i.expert
OHT
Light Based Over-the-counter Hair Removal
27d
Cleared
Apr 27, 2023
ArtiSential Laparoscopic Instruments-Electrodes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
59d
Cleared
Apr 27, 2023
Renuvion® APR Handpiece
GEI
Electrosurgical, Cutting & Coagulation & Accessories
86d
Cleared
Apr 27, 2023
Epildream HP 4000 MED
GEX
Powered Laser Surgical Instrument
266d
Cleared
Apr 26, 2023
ArtiSential Laparoscopic Instruments-Electrodes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
61d
Cleared
Apr 25, 2023
IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG
OHT
Light Based Over-the-counter Hair Removal
56d
Cleared
Apr 21, 2023
OmniGuide RFID Surgical Laser Fibers
GEX
Powered Laser Surgical Instrument
28d
Cleared
Apr 21, 2023
Intense Pulsed Light Treatment System
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
28d
Cleared
Apr 21, 2023
Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument
KNW
Instrument, Biopsy
176d
Cleared
Apr 21, 2023
AEON Endoscopic Stapler
GDW
Staple, Implantable
270d
Not Cleared
Apr 20, 2023
Breast Implant Removal Device (BIRD)
QVS
Breast Implant Suction Retrieval Device
150d
Cleared
Apr 19, 2023
Diode Laser Hair Removal
OHT
Light Based Over-the-counter Hair Removal
97d
Cleared
Apr 19, 2023
TAP Lancet
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
187d
Cleared
Apr 19, 2023
Renova RP Centesis Pump
BTA
Pump, Portable, Aspiration (manual Or Powered)
376d
Cleared
Apr 18, 2023
SofWave System
OHV
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
25d
Cleared
Apr 18, 2023
Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200
GEI
Electrosurgical, Cutting & Coagulation & Accessories
123d
Cleared
Apr 13, 2023
Symmed Elite Aesthetic
PBX
Massager, Vacuum, Radio Frequency Induced Heat
57d
Cleared
Apr 13, 2023
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
58d
Cleared
Apr 11, 2023
L12 LED Light Source with AIM
OWN
Confocal Optical Imaging
25d
Cleared
Apr 10, 2023
IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02
OHT
Light Based Over-the-counter Hair Removal
59d
Cleared
Apr 10, 2023
IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
OHT
Light Based Over-the-counter Hair Removal
83d
Cleared
Apr 07, 2023
Enivo™
BTA
Pump, Portable, Aspiration (manual Or Powered)
154d
Cleared
Apr 07, 2023
Peri-Guard and Supple Peri-Guard
FTM
Mesh, Surgical
190d
Cleared
Apr 07, 2023
Axiostat Gauze
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
193d
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