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
Nov 19, 2019
L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable
OWN
Confocal Optical Imaging
88d
Cleared
Nov 19, 2019
TwinScan 808/755 Laser System
GEX
Powered Laser Surgical Instrument
90d
Cleared
Nov 18, 2019
JTL-250-01
MUU
System, Suction, Lipoplasty
416d
Cleared
Nov 15, 2019
SPY Portable Handheld Imaging (SPY-PHI) System
OWN
Confocal Optical Imaging
95d
Cleared
Nov 14, 2019
E-100 Electrosurgical Generator, SynchroSeal
NAY
System, Surgical, Computer Controlled Instrument
185d
Cleared
Nov 12, 2019
LaseMD LEO Laser System
GEX
Powered Laser Surgical Instrument
77d
Cleared
Nov 08, 2019
IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
OHT
Light Based Over-the-counter Hair Removal
64d
Cleared
Nov 07, 2019
EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G
KNW
Instrument, Biopsy
20d
Cleared
Nov 07, 2019
Laparoscope Lens Shield Device (LENS)
GCJ
Laparoscope, General & Plastic Surgery
28d
Cleared
Nov 07, 2019
Progenikine Concentrating System 25 mL System
MUU
System, Suction, Lipoplasty
147d
Cleared
Nov 07, 2019
DemeDIOX Barbed Absorbable Surgical Suture
NEW
Suture, Surgical, Absorbable, Polydioxanone
170d
Cleared
Nov 06, 2019
Hydrofera Blue READY - Border
FRO
Dressing, Wound, Drug
271d
Cleared
Nov 01, 2019
BC-5
GEX
Powered Laser Surgical Instrument
129d
Cleared
Nov 01, 2019
MIMOSA Imager
MUD
Oximeter, Tissue Saturation
260d
Cleared
Nov 01, 2019
Foryou NPWT Dressing Kit
OMP
Negative Pressure Wound Therapy Powered Suction Pump
281d
Cleared
Oct 31, 2019
Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
24d
Cleared
Oct 31, 2019
Claritag
GEH
Unit, Cryosurgical, Accessories
223d
Cleared
Oct 31, 2019
Ultrasonic Surgical System
LFL
Instrument, Ultrasonic Surgical
262d
Cleared
Oct 29, 2019
EmFace Device
PBX
Massager, Vacuum, Radio Frequency Induced Heat
111d
Cleared
Oct 28, 2019
KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
LEJ
Booth, Sun Tan
105d
Cleared
Oct 28, 2019
HS AMICA devices family
GEI
Electrosurgical, Cutting & Coagulation & Accessories
402d
Cleared
Oct 25, 2019
Cytal Wound Matrix 3-Layer
KGN
Wound Dressing With Animal-derived Material(s)
28d
Cleared
Oct 25, 2019
gel-e Flex+ gel OTC
QSY
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
30d
Cleared
Oct 25, 2019
Reusable Monopolar Active Cord
GEI
Electrosurgical, Cutting & Coagulation & Accessories
42d
Cleared
Oct 24, 2019
Agnes
GEI
Electrosurgical, Cutting & Coagulation & Accessories
27d
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