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
18256
Total
18211
Cleared
136d
Avg (2y)
1976
Since
7582 General & Plastic Surgery devices
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
Cleared
Oct 11, 2022
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
GCJ
Laparoscope, General & Plastic Surgery
88d
Cleared
Oct 11, 2022
Apyx One Console
GEI
Electrosurgical, Cutting & Coagulation & Accessories
110d
Cleared
Oct 07, 2022
PURE Laser
GEX
Powered Laser Surgical Instrument
63d
Cleared
Oct 07, 2022
Cold Sore Device (Model: QPZ-01)
OKJ
Light Based Treatment For Cold Sores Herpes Simplex Virus-1
74d
Cleared
Oct 07, 2022
Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps
GEI
Electrosurgical, Cutting & Coagulation & Accessories
326d
Cleared
Oct 05, 2022
Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP
GEI
Electrosurgical, Cutting & Coagulation & Accessories
260d
Cleared
Oct 03, 2022
Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
59d
Cleared
Oct 03, 2022
Disposable Safety Lancets
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
104d
Cleared
Oct 03, 2022
Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
QRL
Multiple Use Blood Lancet For Single Patient Use Only
122d
Cleared
Oct 03, 2022
Aurolase Therapy, Laser Delivery Device (LDD)
GEX
Powered Laser Surgical Instrument
733d
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