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
1308 General & Plastic Surgery devices
Cleared
Dec 26, 2024
FISIOWARM 7.0
PBX
Massager, Vacuum, Radio Frequency Induced Heat
462d
Cleared
Dec 23, 2024
Electrosurgical Generator (ES-100)
GEI
Electrosurgical, Cutting & Coagulation & Accessories
257d
Cleared
Dec 23, 2024
Genadyne DUO NPWT
OMP
Negative Pressure Wound Therapy Powered Suction Pump
406d
Cleared
Dec 22, 2024
SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA
GEX
Powered Laser Surgical Instrument
83d
Cleared
Dec 21, 2024
LGO-Surgical Laser Fibers
GEX
Powered Laser Surgical Instrument
82d
Cleared
Dec 21, 2024
IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)
OHT
Light Based Over-the-counter Hair Removal
82d
Cleared
Dec 20, 2024
LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)
OHS
Light Based Over The Counter Wrinkle Reduction
84d
Cleared
Dec 20, 2024
Finiff System
GEI
Electrosurgical, Cutting & Coagulation & Accessories
105d
Cleared
Dec 20, 2024
HandPICO Fractional Laser Handpiece Tip
GEX
Powered Laser Surgical Instrument
116d
Cleared
Dec 20, 2024
Fractional CO2 Laser Therapy System (FG900-S)
GEX
Powered Laser Surgical Instrument
192d
Cleared
Dec 20, 2024
SmartClip Secure Soft Tissue Marker
NEU
Marker, Radiographic, Implantable
403d
Cleared
Dec 19, 2024
OviTex PRS (Long-Term Resorbable)
FTM
Mesh, Surgical
29d
Cleared
Dec 19, 2024
Bovine Dermis Collagen Dermal Matrix
KGN
Wound Dressing With Animal-derived Material(s)
83d
Cleared
Dec 19, 2024
UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD)
FTC
Light, Ultraviolet, Dermatological
86d
Cleared
Dec 19, 2024
Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B)
OHS
Light Based Over The Counter Wrinkle Reduction
101d
Cleared
Dec 19, 2024
Medline Microdissection Needle (4cm) (140936 (ESE104A))
GEI
Electrosurgical, Cutting & Coagulation & Accessories
132d
Cleared
Dec 17, 2024
Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
GEX
Powered Laser Surgical Instrument
82d
Cleared
Dec 17, 2024
BIOBRANE Temporary Wound Dressing
KGN
Wound Dressing With Animal-derived Material(s)
147d
Cleared
Dec 16, 2024
da Vinci Surgical System (IS5000)
NAY
System, Surgical, Computer Controlled Instrument
20d
Cleared
Dec 16, 2024
LUOFUCON® Silver Collagen Dressing
FRO
Dressing, Wound, Drug
266d
Cleared
Dec 13, 2024
LCD Monitor (MDEC-2523)
GCJ
Laparoscope, General & Plastic Surgery
53d
Cleared
Dec 13, 2024
Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
OHT
Light Based Over-the-counter Hair Removal
157d
Cleared
Dec 12, 2024
Medicon Epiplating System
FZE
Prosthesis, Nose, Internal
223d
Cleared
Dec 11, 2024
FAQ™ (302)
OAP
Laser, Comb, Hair
90d
Cleared
Dec 11, 2024
Radiofrequency Generator System, Cura RF Electrode
GEI
Electrosurgical, Cutting & Coagulation & Accessories
266d
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