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
18201
Total
18157
Cleared
138d
Avg (2y)
1976
Since
3927 General & Plastic Surgery devices
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
Not Cleared
Apr 07, 2023
The N-SWEAT Patch
QVX
Skin Patch For Treatment Of Hyperhidrosis
490d
Cleared
Apr 06, 2023
IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
OHT
Light Based Over-the-counter Hair Removal
83d
Cleared
Apr 05, 2023
CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)
OAP
Laser, Comb, Hair
57d
Cleared
Apr 05, 2023
Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588
OHT
Light Based Over-the-counter Hair Removal
82d
Cleared
Apr 05, 2023
Da Vinci SP Surgical System (SP1098)
NAY
System, Surgical, Computer Controlled Instrument
90d
Cleared
Apr 05, 2023
Antimicrobial Silicone PHMB Foam Wound Dressing
FRO
Dressing, Wound, Drug
159d
Cleared
Apr 05, 2023
FAQ 101
PAY
Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction
271d
Cleared
Apr 03, 2023
M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle
KNW
Instrument, Biopsy
193d
Cleared
Mar 31, 2023
1788 4K Camera System with Advanced Imaging Modality
GCJ
Laparoscope, General & Plastic Surgery
28d
Cleared
Mar 31, 2023
Medical Diode Laser (M2)
GEX
Powered Laser Surgical Instrument
58d
Cleared
Mar 31, 2023
IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32
OHT
Light Based Over-the-counter Hair Removal
86d
Cleared
Mar 31, 2023
Diode Laser Hair Removal System (RD-SLD600)
GEX
Powered Laser Surgical Instrument
105d
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