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
1305 General & Plastic Surgery devices
Cleared
Feb 19, 2025
Phasix ST Umbilical Hernia Patch
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
132d
Cleared
Feb 18, 2025
RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port
OMP
Negative Pressure Wound Therapy Powered Suction Pump
91d
Cleared
Feb 14, 2025
CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)
OHS
Light Based Over The Counter Wrinkle Reduction
168d
Cleared
Feb 14, 2025
WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
GEX
Powered Laser Surgical Instrument
252d
Cleared
Feb 14, 2025
Pastelle Pro
GEX
Powered Laser Surgical Instrument
260d
Cleared
Feb 13, 2025
Unicorn+ RF System (Unicorn+)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
233d
Cleared
Feb 11, 2025
InbellaBody System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
19d
Cleared
Feb 10, 2025
Philips Lumea IPL
OHT
Light Based Over-the-counter Hair Removal
95d
Cleared
Feb 07, 2025
HELIOS 785 Pico (1754V2)
GEX
Powered Laser Surgical Instrument
60d
Cleared
Feb 07, 2025
Symani Surgical System
SAQ
Electromechanical System For Open Microsurgery
182d
Cleared
Feb 06, 2025
Diode Laser Hair Removal Device (EVOLUTION MEDICAL)
GEX
Powered Laser Surgical Instrument
90d
Cleared
Feb 06, 2025
308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
FTC
Light, Ultraviolet, Dermatological
133d
Cleared
Feb 05, 2025
LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
OLP
Over-the-counter Powered Light Based Laser For Acne
79d
Cleared
Feb 05, 2025
CROMA Electrosurgical Generator (PRD-EMR-050)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
132d
Cleared
Feb 04, 2025
Venclose digiRF Generator (VCRFG1)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
25d
Cleared
Feb 03, 2025
Anovo Instrument ARM Curved Scissors
QNM
Mountable Electromechanical Surgical System For Transluminal Approaches
126d
Cleared
Jan 30, 2025
BTL-754
GEX
Powered Laser Surgical Instrument
269d
Cleared
Jan 29, 2025
Self-Forming Magnet (FLEX SFM)
SAH
Magnetic Compression Anastomosis System
118d
Cleared
Jan 29, 2025
Co-Ablation System with Sterile Co-Ablation Probe
GEH
Unit, Cryosurgical, Accessories
124d
Cleared
Jan 28, 2025
Medical Monitor (27HS714S)
GCJ
Laparoscope, General & Plastic Surgery
83d
Cleared
Jan 28, 2025
LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)
OHS
Light Based Over The Counter Wrinkle Reduction
85d
Cleared
Jan 27, 2025
Symani Surgical System (820-03830)
SAQ
Electromechanical System For Open Microsurgery
25d
Cleared
Jan 27, 2025
CO2 Laser Therapy Systems (SHE-LSP003-1)
GEX
Powered Laser Surgical Instrument
124d
Cleared
Jan 24, 2025
Bone Marrow Biopsy Needle
KNW
Instrument, Biopsy
171d
Cleared
Jan 24, 2025
Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
KNW
Instrument, Biopsy
217d
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