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
1294 General & Plastic Surgery devices
Cleared
Nov 04, 2025
Voyant® Open Fusion Device (EB240/Open Fusion)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
68d
Cleared
Nov 04, 2025
Tamburo Thulium Fiber Laser System
GEX
Powered Laser Surgical Instrument
190d
Cleared
Oct 31, 2025
Kii Structural Balloon Access System
GCJ
Laparoscope, General & Plastic Surgery
88d
Cleared
Oct 31, 2025
Diode Laser Hair Removal Machine (GLD01)
GEX
Powered Laser Surgical Instrument
91d
Cleared
Oct 31, 2025
Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
91d
Cleared
Oct 30, 2025
ellacor System with Micro-Coring Technology
QAI
Powered Microneedle Device
62d
Cleared
Oct 30, 2025
Moses™ 200 D/F/L Laser Fiber (M0068130100)
GEX
Powered Laser Surgical Instrument
80d
Cleared
Oct 30, 2025
Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
OAP
Laser, Comb, Hair
90d
Cleared
Oct 29, 2025
SER Pen Carain MicroSystem (MP1209SP)
QAI
Powered Microneedle Device
33d
Cleared
Oct 29, 2025
3D Laparoscope
GCJ
Laparoscope, General & Plastic Surgery
63d
Cleared
Oct 28, 2025
PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch
GEI
Electrosurgical, Cutting & Coagulation & Accessories
270d
Cleared
Oct 27, 2025
VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)
OHS
Light Based Over The Counter Wrinkle Reduction
118d
Cleared
Oct 27, 2025
Patriot Duo
GEX
Powered Laser Surgical Instrument
136d
Cleared
Oct 24, 2025
Parietene™ Flat Sheet Mesh
FTL
Mesh, Surgical, Polymeric
29d
Cleared
Oct 23, 2025
MultiPulse TFL
GEX
Powered Laser Surgical Instrument
29d
Cleared
Oct 23, 2025
1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
GEX
Powered Laser Surgical Instrument
56d
Cleared
Oct 23, 2025
Picosecond Laser Device (PF131-BI)
GEX
Powered Laser Surgical Instrument
87d
Cleared
Oct 22, 2025
Hair Growth Laser Cap
OAP
Laser, Comb, Hair
89d
Cleared
Oct 21, 2025
ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
277d
Cleared
Oct 20, 2025
VereSee Optical Veres Needle and Endoscopic Camera
GCJ
Laparoscope, General & Plastic Surgery
60d
Cleared
Oct 20, 2025
Q-Switched Nd: YAG Laser machine (LFS-C13U)
GEX
Powered Laser Surgical Instrument
87d
Cleared
Oct 20, 2025
AVAVA™ Skin Treatment System
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
103d
Cleared
Oct 20, 2025
Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)
NEW
Suture, Surgical, Absorbable, Polydioxanone
166d
Cleared
Oct 17, 2025
MEGELIN LED Light Therapy Mask (JML1, JML1+JML2)
OHS
Light Based Over The Counter Wrinkle Reduction
88d
Cleared
Oct 16, 2025
TargetCool™ (RM-DT02W)
GEH
Unit, Cryosurgical, Accessories
22d
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