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
Oct 03, 2025
TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
GEX
Powered Laser Surgical Instrument
143d
Cleared
Oct 03, 2025
da Vinci SP Surgical System (SP1098)
NAY
System, Surgical, Computer Controlled Instrument
148d
Cleared
Oct 03, 2025
Revolve Surgical System
GCJ
Laparoscope, General & Plastic Surgery
284d
Cleared
Oct 03, 2025
HESTIA (L200-A)
GEX
Powered Laser Surgical Instrument
373d
Not Cleared
Oct 03, 2025
ProSense™ System
QXW
Cryoablation Device For Local Treatment Of Low-risk Breast Cancer
1080d
Cleared
Oct 02, 2025
IPL Hair Removal Device (IPL-001, IPL-002)
OHT
Light Based Over-the-counter Hair Removal
149d
Cleared
Oct 02, 2025
4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
GCJ
Laparoscope, General & Plastic Surgery
219d
Cleared
Oct 01, 2025
Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG
OHT
Light Based Over-the-counter Hair Removal
28d
Cleared
Oct 01, 2025
Picosecond laser device (BMPS4)
GEX
Powered Laser Surgical Instrument
58d
Cleared
Oct 01, 2025
Light Therapy Decollete Mask (1019135)
OHS
Light Based Over The Counter Wrinkle Reduction
90d
Cleared
Oct 01, 2025
E Blator
GEI
Electrosurgical, Cutting & Coagulation & Accessories
103d
Cleared
Oct 01, 2025
Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
OHS
Light Based Over The Counter Wrinkle Reduction
110d
Cleared
Sep 30, 2025
Dexter L6 System
SDD
Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
166d
Cleared
Sep 29, 2025
NEW DOUBLO 2.0
GEI
Electrosurgical, Cutting & Coagulation & Accessories
152d
Cleared
Sep 26, 2025
Magnetic Surgical System
PNL
Magnetic Surgical System
56d
Cleared
Sep 26, 2025
Thulium Laser System (Deluxlase)
GEX
Powered Laser Surgical Instrument
95d
Cleared
Sep 25, 2025
Medical Diode Laser Systems (BERYLAS-12N)
GEX
Powered Laser Surgical Instrument
86d
Cleared
Sep 24, 2025
Resitu Slider 09 (RESL09)
KNW
Instrument, Biopsy
75d
Cleared
Sep 24, 2025
Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories
GEX
Powered Laser Surgical Instrument
257d
Cleared
Sep 23, 2025
PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture
NEW
Suture, Surgical, Absorbable, Polydioxanone
33d
Cleared
Sep 23, 2025
Luminance Red Cold Sore Device (TN1927G)
OKJ
Light Based Treatment For Cold Sores Herpes Simplex Virus-1
89d
Cleared
Sep 22, 2025
SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System
GCJ
Laparoscope, General & Plastic Surgery
108d
Cleared
Sep 22, 2025
IC-Flow™ Imaging System 2.0
IZI
System, X-ray, Angiographic
300d
Cleared
Sep 19, 2025
BondEase 2 Topical Skin Adhesive
MPN
Tissue Adhesive For The Topical Approximation Of Skin
267d
Cleared
Sep 19, 2025
VEGA
GEX
Powered Laser Surgical Instrument
364d
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