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
May 18, 2022
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
49d
Cleared
May 18, 2022
The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
GEX
Powered Laser Surgical Instrument
90d
Cleared
May 18, 2022
MolecuLight I:X
QJF
Autofluorescence Imaging Adjunct Tool For Wounds
160d
Cleared
May 17, 2022
Heel Stick Safety Lancet (HHZ-II, HHZ-III)
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
97d
Cleared
May 17, 2022
Skin Care Beauty Mask (Model: MJ-06)
OHS
Light Based Over The Counter Wrinkle Reduction
117d
Cleared
May 16, 2022
IPL HAIR REMOVAL HANDSET, Model: IPL-666
OHT
Light Based Over-the-counter Hair Removal
70d
Cleared
May 13, 2022
Pre-Formed Penile Silicone Block
MIB
Elastomer, Silicone Block
59d
Cleared
May 13, 2022
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
88d
Cleared
May 13, 2022
Zone Specific AIM
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
109d
Cleared
May 12, 2022
IPL Home Use Hair Removal Device
OHT
Light Based Over-the-counter Hair Removal
38d
Cleared
May 12, 2022
Laser hair growth helmet
OAP
Laser, Comb, Hair
233d
Cleared
May 06, 2022
Masimo O3 Regional Oximeter System
MUD
Oximeter, Tissue Saturation
130d
Cleared
May 05, 2022
GIA Auto Suture Stapler with DST Series Technology
GDW
Staple, Implantable
30d
Cleared
May 05, 2022
HandPICO
GEX
Powered Laser Surgical Instrument
120d
Cleared
May 03, 2022
Intra.Ox 2.0 Handheld Tissue Oximeter
MUD
Oximeter, Tissue Saturation
28d
Cleared
May 03, 2022
ECHOLASER X4
GEX
Powered Laser Surgical Instrument
172d
Cleared
Apr 29, 2022
GIA Stapler with Tri-Staple Technology
GDW
Staple, Implantable
24d
Cleared
Apr 29, 2022
EEA Circular Stapler with Tri-Staple Technology
GDW
Staple, Implantable
24d
Cleared
Apr 29, 2022
Accu-Chek FastClix Blood Lancing System
QRL
Multiple Use Blood Lancet For Single Patient Use Only
58d
Cleared
Apr 29, 2022
LISA Laser Surgical Fibers
GEX
Powered Laser Surgical Instrument
95d
Cleared
Apr 28, 2022
Geistlich Wound Matrix PLUS
KGN
Wound Dressing With Animal-derived Material(s)
164d
Cleared
Apr 27, 2022
Hand-held IPL device (JOVS Hair Removal Device)
OHT
Light Based Over-the-counter Hair Removal
54d
Cleared
Apr 27, 2022
Venus BlissMAX
PBX
Massager, Vacuum, Radio Frequency Induced Heat
57d
Cleared
Apr 26, 2022
IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
OHT
Light Based Over-the-counter Hair Removal
90d
Cleared
Apr 26, 2022
PERMALOOP Suture, PERMATAPE Suture
GAT
Suture, Nonabsorbable, Synthetic, Polyethylene
90d
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