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
Oct 25, 2022
Unistik® Pro
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
85d
Cleared
Oct 24, 2022
SafetiCET Safety Lancet
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
125d
Cleared
Oct 21, 2022
Collagen P.I.N. (Percutaneous Induction Needling)
QAI
Powered Microneedle Device
91d
Cleared
Oct 21, 2022
Hair Removal Device (Model: IPL-D26, IPL-D19)
OHT
Light Based Over-the-counter Hair Removal
137d
Cleared
Oct 20, 2022
da Vinci Firefly Imaging System
NAY
System, Surgical, Computer Controlled Instrument
31d
Cleared
Oct 20, 2022
SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)
GCJ
Laparoscope, General & Plastic Surgery
127d
Cleared
Oct 19, 2022
RADIANCE ULTRA 32 4K ZEROWIRE DUO
GCJ
Laparoscope, General & Plastic Surgery
26d
Cleared
Oct 19, 2022
SOMAVAC 100 Sustained Vacuum System
BTA
Pump, Portable, Aspiration (manual Or Powered)
28d
Cleared
Oct 19, 2022
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
PBY
Temporary Tissue Marker
48d
Cleared
Oct 18, 2022
MEBO Wound Dressing
FRO
Dressing, Wound, Drug
46d
Cleared
Oct 18, 2022
TRUEdraw Lancing Device, Mini Lancing Device
QRL
Multiple Use Blood Lancet For Single Patient Use Only
189d
Cleared
Oct 17, 2022
WavelinQ™ Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
31d
Cleared
Oct 17, 2022
Multi-Lancet Device 2, ReliOn Premier Lancing Device
QRL
Multiple Use Blood Lancet For Single Patient Use Only
175d
Cleared
Oct 16, 2022
LUDWIG Electrosurgical Device
GEI
Electrosurgical, Cutting & Coagulation & Accessories
137d
Cleared
Oct 14, 2022
IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
OHT
Light Based Over-the-counter Hair Removal
53d
Cleared
Oct 14, 2022
Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
74d
Cleared
Oct 14, 2022
BD Surgiphor™ Antimicrobial Irrigation System
FQH
Lavage, Jet
144d
Cleared
Oct 14, 2022
PAL Infiltration System
QPB
System, Suction, Lipoplasty For Removal
253d
Cleared
Oct 13, 2022
ID-510 iRestore Elite
OAP
Laser, Comb, Hair
90d
Cleared
Oct 13, 2022
The Oligio
GEI
Electrosurgical, Cutting & Coagulation & Accessories
99d
Cleared
Oct 13, 2022
Fiber Laser Treatment System
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
114d
Cleared
Oct 13, 2022
PicoWay Laser System
GEX
Powered Laser Surgical Instrument
204d
Cleared
Oct 12, 2022
The Alma Soprano Titanium
GEX
Powered Laser Surgical Instrument
91d
Cleared
Oct 12, 2022
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
GEX
Powered Laser Surgical Instrument
121d
Cleared
Oct 11, 2022
IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439
OHT
Light Based Over-the-counter Hair Removal
60d
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