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 18, 2022
SiOxD Wound Matrix
QSZ
Absorbable Synthetic Wound Dressing
119d
Cleared
Nov 17, 2022
easy Claire
OHS
Light Based Over The Counter Wrinkle Reduction
24d
Cleared
Nov 17, 2022
Alexandrite and Nd:YAG Laser models CANLASE and TORLASE
GEX
Powered Laser Surgical Instrument
72d
Cleared
Nov 17, 2022
IPL Hair Removal Device
OHT
Light Based Over-the-counter Hair Removal
80d
Cleared
Nov 17, 2022
Accure Laser
GEX
Powered Laser Surgical Instrument
122d
Cleared
Nov 17, 2022
C.C. LIFE 21
PBX
Massager, Vacuum, Radio Frequency Induced Heat
412d
Cleared
Nov 17, 2022
Supra Non-Stick Bipolar Forceps
GEI
Electrosurgical, Cutting & Coagulation & Accessories
421d
Cleared
Nov 17, 2022
TFX-LT2000 Therapy Light
PDZ
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
570d
Cleared
Nov 16, 2022
Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)
OAP
Laser, Comb, Hair
104d
Cleared
Nov 15, 2022
Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS
GEX
Powered Laser Surgical Instrument
50d
Cleared
Nov 15, 2022
Disposable Sterile Lancet
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
126d
Cleared
Nov 15, 2022
STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
152d
Cleared
Nov 10, 2022
H1
GCJ
Laparoscope, General & Plastic Surgery
84d
Cleared
Nov 10, 2022
10PL
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
237d
Cleared
Nov 10, 2022
Dermal Cooling System
QPZ
Contact Cooling For Skin Lesion Pain Relief
405d
Cleared
Nov 07, 2022
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)
GEX
Powered Laser Surgical Instrument
52d
Cleared
Nov 03, 2022
truSculpt iD
GEI
Electrosurgical, Cutting & Coagulation & Accessories
31d
Cleared
Nov 03, 2022
Led Mask Platinum Md
OHS
Light Based Over The Counter Wrinkle Reduction
90d
Cleared
Nov 03, 2022
Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
105d
Cleared
Nov 02, 2022
OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
110d
Cleared
Nov 01, 2022
Back 3 COLOR
PBX
Massager, Vacuum, Radio Frequency Induced Heat
308d
Cleared
Oct 28, 2022
VS3-Iridium System (VS3-IR)
OWN
Confocal Optical Imaging
29d
Cleared
Oct 28, 2022
Disposable Safety Lancet
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
156d
Cleared
Oct 27, 2022
Arthrex BioSuture
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
216d
Cleared
Oct 26, 2022
Silverlon Wound Contact, Burn Contact Dressings
FRO
Dressing, Wound, Drug
182d
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