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
Apr 28, 2022
Geistlich Wound Matrix PLUS
KGN
Wound Dressing With Animal-derived Material(s)
164d
Cleared
Apr 27, 2022
Hand-held IPL device (JOVS Hair Removal Device)
OHT
Light Based Over-the-counter Hair Removal
54d
Cleared
Apr 27, 2022
Venus BlissMAX
PBX
Massager, Vacuum, Radio Frequency Induced Heat
57d
Cleared
Apr 26, 2022
IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
OHT
Light Based Over-the-counter Hair Removal
90d
Cleared
Apr 26, 2022
PERMALOOP Suture, PERMATAPE Suture
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
90d
Cleared
Apr 22, 2022
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)
GCJ
Laparoscope, General & Plastic Surgery
25d
Cleared
Apr 22, 2022
1 Series Phototherapy Equipment
FTC
Light, Ultraviolet, Dermatological
30d
Cleared
Apr 22, 2022
PicoStar
GEX
Powered Laser Surgical Instrument
130d
Cleared
Apr 22, 2022
Promisemed Fine Biopsy Needle
KNW
Instrument, Biopsy
151d
Cleared
Apr 22, 2022
LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
FRO
Dressing, Wound, Drug
372d
Cleared
Apr 22, 2022
CoNextions TR Tendon Repair System
GAQ
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
477d
Cleared
Apr 21, 2022
HydroMARK Breast Biopsy Site Marker
NEU
Marker, Radiographic, Implantable
283d
Cleared
Apr 21, 2022
Waterlase iPLus
GEX
Powered Laser Surgical Instrument
451d
Cleared
Apr 20, 2022
Saberscope5 Laparoscope
GCJ
Laparoscope, General & Plastic Surgery
26d
Cleared
Apr 20, 2022
Auxo A300, A150 and APod
OAP
Laser, Comb, Hair
54d
Cleared
Apr 20, 2022
GEM FLOW COUPLER Monitor (GEM1020M-2)
DPW
Flowmeter, Blood, Cardiovascular
121d
Cleared
Apr 20, 2022
SmoothCool HR System
GEX
Powered Laser Surgical Instrument
173d
Cleared
Apr 15, 2022
mJOULE System and Accessories
GEX
Powered Laser Surgical Instrument
189d
Cleared
Apr 13, 2022
MCL 31 Dermablate System
GEX
Powered Laser Surgical Instrument
406d
Cleared
Apr 12, 2022
LED Therapy Device (Planar LED/Planar LED mini)
GEX
Powered Laser Surgical Instrument
90d
Cleared
Apr 12, 2022
Finexel
GEX
Powered Laser Surgical Instrument
155d
Cleared
Apr 11, 2022
Cellvizio 100 series system with confocal Miniprobes
OWN
Confocal Optical Imaging
52d
Cleared
Apr 11, 2022
Intense Pulsed Light (IPL) System
OHT
Light Based Over-the-counter Hair Removal
213d
Cleared
Apr 08, 2022
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
GAG
Stapler, Surgical
142d
Cleared
Apr 08, 2022
SCOUT BX Delivery System
NEU
Marker, Radiographic, Implantable
210d
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