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
1299 General & Plastic Surgery devices
Cleared
Jun 07, 2025
Magnetic Surgical System
PNL
Magnetic Surgical System
87d
Cleared
Jun 06, 2025
Light Therapy System (M500, L6)
OHS
Light Based Over The Counter Wrinkle Reduction
64d
Cleared
Jun 06, 2025
Nd: YAG Laser Therapy System (QN-1)
GEX
Powered Laser Surgical Instrument
88d
Cleared
Jun 06, 2025
Anovo Surgical System (6Ne)
QNM
Mountable Electromechanical Surgical System For Transluminal Approaches
99d
Cleared
Jun 06, 2025
DELPHI System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
255d
Cleared
Jun 06, 2025
Discovery Pico
GEX
Powered Laser Surgical Instrument
422d
Cleared
Jun 05, 2025
Red Light Hair Growth Cap (LP-RJVGRW-BLK)
OAP
Laser, Comb, Hair
107d
Cleared
Jun 03, 2025
gi2000 Electrosurgical Generator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
90d
Cleared
Jun 03, 2025
Endoform Reconstructive Template - PLGA
FTM
Mesh, Surgical
95d
Cleared
May 30, 2025
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
38d
Cleared
May 30, 2025
KALA Red Light Face Mask (KALA-01)
OHS
Light Based Over The Counter Wrinkle Reduction
92d
Cleared
May 30, 2025
MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
GEX
Powered Laser Surgical Instrument
127d
Cleared
May 28, 2025
Zionic Pro Max (Radiofrequency)
PBX
Massager, Vacuum, Radio Frequency Induced Heat
177d
Cleared
May 27, 2025
Dexter L6 System
SDD
Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
102d
Cleared
May 23, 2025
Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK
OHT
Light Based Over-the-counter Hair Removal
56d
Cleared
May 23, 2025
IPL400
OHT
Light Based Over-the-counter Hair Removal
101d
Cleared
May 22, 2025
Skin Clinic Freeze Point for Warts and Skin Tags
GEH
Unit, Cryosurgical, Accessories
7d
Cleared
May 22, 2025
Solawave 2-in-1 Skincare Mini (Model: 61043)
OHS
Light Based Over The Counter Wrinkle Reduction
87d
Cleared
May 21, 2025
The Alma Hybrid Laser System
GEX
Powered Laser Surgical Instrument
30d
Cleared
May 21, 2025
3DMatrix DynaFlex (DynaFlex)
OXF
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
215d
Cleared
May 19, 2025
Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
ILY
Lamp, Infrared, Therapeutic Heating
249d
Cleared
May 16, 2025
BLESSING System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
228d
Cleared
May 15, 2025
NPseal
OKO
Negative Pressure Wound Therapy Non-powered Suction Apparatus
30d
Cleared
May 15, 2025
Youmagic FLM System (YM5-U1)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
413d
Cleared
May 14, 2025
Veincare
GEX
Powered Laser Surgical Instrument
19d
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