FDA 510(k) General & Plastic Surgery Devices
FDA 510(k) General & Plastic Surgery Devices - Regulatory Overview
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
18256
Total
18211
Cleared
136d
Avg (2y)
1976
Since
7517 General & Plastic Surgery devices
Cleared
Oct 10, 2025
Verruca-Freeze H Plus
GEH
Unit, Cryosurgical, Accessories
29d
Cleared
Oct 10, 2025
IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)
OHT
Light Based Over-the-counter Hair Removal
87d
Cleared
Oct 10, 2025
Collagen Wound Dressing
KGN
Wound Dressing With Animal-derived Material(s)
105d
Cleared
Oct 10, 2025
Tegaderm Post-Op Transparent Antimicrobial Dressing
FRO
Dressing, Wound, Drug
115d
Cleared
Oct 09, 2025
ORA Method LED Gua Sha (GS-04)
OHS
Light Based Over The Counter Wrinkle Reduction
79d
Cleared
Oct 08, 2025
The Botticelli (Model: Athena)
GEX
Powered Laser Surgical Instrument
128d
Cleared
Oct 08, 2025
CUSA® Clarity Ultrasonic Surgical Aspirator System
LFL
Instrument, Ultrasonic Surgical
176d
Cleared
Oct 07, 2025
deepLive (OSP12 + DMS)
NQQ
System, Imaging, Optical Coherence Tomography (oct)
29d
Cleared
Oct 07, 2025
Ultrasonic Bipolar Generator (USG-410)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
90d
Cleared
Oct 07, 2025
Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
215d
Cleared
Oct 03, 2025
PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso)
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
29d
Cleared
Oct 03, 2025
extriCARE® 1000 Negative Pressure Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
127d
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
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