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
18288
Total
18243
Cleared
138d
Avg (2y)
1976
Since
13535 General & Plastic Surgery devices
Cleared
Jun 03, 2022
MICROLET NEXT lancing device, MICROLET Lancet
QRL
Multiple Use Blood Lancet For Single Patient Use Only
91d
Cleared
Jun 03, 2022
Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
KNW
Instrument, Biopsy
158d
Cleared
Jun 03, 2022
Multifrax Laser System
ONG
Powered Laser Surgical Instrument With Microbeamfractional Output
240d
Cleared
Jun 03, 2022
SILKRO
GEI
Electrosurgical, Cutting & Coagulation & Accessories
507d
Cleared
Jun 02, 2022
IPL Hair Removal
OHT
Light Based Over-the-counter Hair Removal
63d
Cleared
Jun 02, 2022
Leaseir MHR Xcell
GEX
Powered Laser Surgical Instrument
157d
Cleared
Jun 02, 2022
EpilME
GEX
Powered Laser Surgical Instrument
245d
Cleared
Jun 01, 2022
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
OHT
Light Based Over-the-counter Hair Removal
58d
Cleared
Jun 01, 2022
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
OMP
Negative Pressure Wound Therapy Powered Suction Pump
502d
Cleared
May 31, 2022
Fibrillar Collagen Wound Dressing
KGN
Wound Dressing With Animal-derived Material(s)
236d
Cleared
May 31, 2022
Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
OMP
Negative Pressure Wound Therapy Powered Suction Pump
375d
Cleared
May 31, 2022
IRRIGO Wound Wash Jet System
FQH
Lavage, Jet
425d
Cleared
May 27, 2022
Senhance Surgical System
NAY
System, Surgical, Computer Controlled Instrument
60d
Cleared
May 26, 2022
Laser Hair Growth Comb
OAP
Laser, Comb, Hair
247d
Cleared
May 25, 2022
InnoVoyce Laser Fiber
GEX
Powered Laser Surgical Instrument
68d
Cleared
May 25, 2022
Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
96d
Cleared
May 25, 2022
780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable
GCJ
Laparoscope, General & Plastic Surgery
149d
Cleared
May 25, 2022
Micro-current facial cold and hot service (model: TPML-100)
OLP
Over-the-counter Powered Light Based Laser For Acne
245d
Cleared
May 25, 2022
Renuvion Dermal Handpiece, Renuvion Dermal System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
362d
Cleared
May 24, 2022
Medline General Surgery Tray
LRO
General Surgery Tray
207d
Cleared
May 23, 2022
LiquiBand XL
OMD
Cutaneous Tissue Adhesive With Mesh
336d
Cleared
May 20, 2022
Diode Laser Therapy Systems
GEX
Powered Laser Surgical Instrument
99d
Cleared
May 20, 2022
Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
OLP
Over-the-counter Powered Light Based Laser For Acne
449d
Cleared
May 19, 2022
Accu-Chek Safe-T-Pro Plus Lancing Device
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
57d
Cleared
May 19, 2022
Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
99d
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