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
Dec 10, 2024
Aerin Console
GEI
Electrosurgical, Cutting & Coagulation & Accessories
98d
Cleared
Dec 10, 2024
POTENZA
GEI
Electrosurgical, Cutting & Coagulation & Accessories
592d
Cleared
Dec 09, 2024
Atrauman® Ag
FRO
Dressing, Wound, Drug
88d
Cleared
Dec 06, 2024
Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)
OHT
Light Based Over-the-counter Hair Removal
88d
Cleared
Dec 03, 2024
Verruca-Freeze H
GEH
Unit, Cryosurgical, Accessories
26d
Cleared
Dec 03, 2024
Sofsilk™ Coated Braided Silk Suture
GAP
Suture, Nonabsorbable, Silk
193d
Cleared
Dec 02, 2024
Riptide™ Aspiration Pump
JCX
Apparatus, Suction, Ward Use, Portable, Ac-powered
28d
Cleared
Dec 02, 2024
GroWell BT Hair Growth System (GW10042)
OAP
Laser, Comb, Hair
90d
Cleared
Nov 27, 2024
SmoothSkin Pure Switch (SSC1)
OHT
Light Based Over-the-counter Hair Removal
29d
Cleared
Nov 27, 2024
CryoGlow (FW3XXXX)
OHS
Light Based Over The Counter Wrinkle Reduction
72d
Cleared
Nov 27, 2024
LED Light Therapy Machine (G1, G3, G4, G6)
OHS
Light Based Over The Counter Wrinkle Reduction
85d
Cleared
Nov 27, 2024
AirSculpt Body Contouring System (AIRS-1-SYS)
QPB
System, Suction, Lipoplasty For Removal
155d
Cleared
Nov 27, 2024
Nexpowder
QAU
Hemostatic Device For Endoscopic Gastrointestinal Use
230d
Cleared
Nov 26, 2024
da Vinci SP Surgical System (SP1098)
NAY
System, Surgical, Computer Controlled Instrument
113d
Cleared
Nov 26, 2024
Cellinew
GEI
Electrosurgical, Cutting & Coagulation & Accessories
239d
Cleared
Nov 22, 2024
Suction Irrigation Tubing Set
GCJ
Laparoscope, General & Plastic Surgery
59d
Cleared
Nov 21, 2024
MIRARI® Cold Plasma System ( GV-M2-01)
PBX
Massager, Vacuum, Radio Frequency Induced Heat
86d
Cleared
Nov 21, 2024
Secret MAX Multi-platform RF System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
209d
Cleared
Nov 20, 2024
INDIBA COMPACT devices
PBX
Massager, Vacuum, Radio Frequency Induced Heat
51d
Cleared
Nov 20, 2024
HIGHERDOSE Red Light Hat (HG-120K)
OAP
Laser, Comb, Hair
103d
Cleared
Nov 19, 2024
Medical Thulium Fiber Laser Systems (UroFiber 60Q)
GEX
Powered Laser Surgical Instrument
109d
Cleared
Nov 18, 2024
da Vinci SP Instruments (SP1098)
NAY
System, Surgical, Computer Controlled Instrument
147d
Cleared
Nov 18, 2024
Tenex 2nd Generation System
LFL
Instrument, Ultrasonic Surgical
158d
Cleared
Nov 18, 2024
Diode laser Treatment System (K18)
GEX
Powered Laser Surgical Instrument
174d
Cleared
Nov 15, 2024
Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX)
QRL
Multiple Use Blood Lancet For Single Patient Use Only
25d
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