FDA 510(k) General & Plastic Surgery Devices
About General & Plastic Surgery Devices
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
18146
Total
18103
Cleared
114d
Avg days
1976
Since
1308 General & Plastic Surgery devices
Cleared
Nov 15, 2024
ArtiSeal Vessel Sealing System-ArtiSeal Instruments
GEI
Electrosurgical, Cutting & Coagulation & Accessories
205d
Cleared
Nov 14, 2024
DEFINE System (AG612444A)
PBX
Massager, Vacuum, Radio Frequency Induced Heat
76d
Cleared
Nov 14, 2024
Intense Pulsed Light Treatment System (LK-PT)
ONF
Powered Light Based Non-laser Surgical Instrument With Thermal Effect
90d
Cleared
Nov 14, 2024
Veincare
GEX
Powered Laser Surgical Instrument
136d
Cleared
Nov 13, 2024
LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
FRO
Dressing, Wound, Drug
54d
Cleared
Nov 08, 2024
décoLITE LED Device
OHS
Light Based Over The Counter Wrinkle Reduction
88d
Cleared
Nov 08, 2024
Superflow Prime Treatment System (ASP-1M)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
98d
Cleared
Nov 08, 2024
Hair Growth Comb (SZ-23,SZ-23A)
OAP
Laser, Comb, Hair
179d
Cleared
Nov 08, 2024
Plasonic (Plasonic)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
200d
Cleared
Nov 08, 2024
Microdacyn Hydrogel
FRO
Dressing, Wound, Drug
260d
Cleared
Nov 07, 2024
Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
OHT
Light Based Over-the-counter Hair Removal
69d
Cleared
Nov 07, 2024
Remanufactured EndoWrist ProGrasp Forceps (420093)
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
133d
Cleared
Nov 07, 2024
Trilogy Tissue Marker
NEU
Marker, Radiographic, Implantable
268d
Cleared
Nov 06, 2024
Compound W Skin Tag Remover
GEH
Unit, Cryosurgical, Accessories
50d
Cleared
Nov 06, 2024
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
OHT
Light Based Over-the-counter Hair Removal
117d
Cleared
Nov 05, 2024
gentleheel® Adult Incision Device
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
62d
Cleared
Nov 05, 2024
POTENZA
GEI
Electrosurgical, Cutting & Coagulation & Accessories
551d
Cleared
Nov 01, 2024
Legend X Desktop System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
29d
Cleared
Nov 01, 2024
Breo Laser Hair Growth Comb (Scalp 3L)
OAP
Laser, Comb, Hair
59d
Cleared
Nov 01, 2024
ORTIV (ORTIV-BL, ORTIV-WH)
GEX
Powered Laser Surgical Instrument
147d
Cleared
Nov 01, 2024
Signia™ Circular Adapter (Standard Length) (SIGCIRSTND)
GAG
Stapler, Surgical
214d
Cleared
Oct 31, 2024
Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo
FRO
Dressing, Wound, Drug
31d
Cleared
Oct 30, 2024
Safety Lancet
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
57d
Cleared
Oct 30, 2024
Edison System
QGM
Focused Ultrasound System For Non-thermal, Mechanical Tissue Ablation
121d
Cleared
Oct 30, 2024
LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)
GCJ
Laparoscope, General & Plastic Surgery
268d
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