FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General & Plastic Surgery ×
18,288 results
385–408 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2025
ORA Method LED Gua Sha (GS-04)
K252272 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 79d
Cleared Oct 08, 2025
The Botticelli (Model: Athena)
K251699 · GEX
Bellamia Technologies, Inc.
General & Plastic Surgery · 128d
Cleared Oct 08, 2025
CUSA® Clarity Ultrasonic Surgical Aspirator System
K251162 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 176d
Cleared Oct 07, 2025
deepLive (OSP12 + DMS)
K252851 · NQQ
Damae Medical
General & Plastic Surgery · 29d
Cleared Oct 07, 2025
Ultrasonic Bipolar Generator (USG-410)
K252150 · GEI
Olympus Medical Systems Corporation
General & Plastic Surgery · 90d
Cleared Oct 07, 2025
Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US)
K250688 · GEI
Acotec Scientific Co., Ltd.
General & Plastic Surgery · 215d
Cleared Oct 03, 2025
PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso)
K252820 · GAM
Internacional Farmac?utica S.A DE C.V
General & Plastic Surgery · 29d
Cleared Oct 03, 2025
extriCARE® 1000 Negative Pressure Wound Therapy System
K251646 · OMP
Alleva Medical Devices
General & Plastic Surgery · 127d
Cleared Oct 03, 2025
TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
K251464 · GEX
Jeisys Medical Incorporated
General & Plastic Surgery · 143d
Cleared Oct 03, 2025
da Vinci SP Surgical System (SP1098)
K251426 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 148d
Cleared Oct 03, 2025
Revolve Surgical System
K243968 · GCJ
Revolve Surgical, Inc.
General & Plastic Surgery · 284d
Cleared Oct 03, 2025
HESTIA (L200-A)
K242946 · GEX
Senbitec Co., Ltd.
General & Plastic Surgery · 373d
Not Cleared Oct 03, 2025
ProSense™ System
DEN220077 · QXW
Icecure Medical
General & Plastic Surgery · 1080d
Cleared Oct 02, 2025
IPL Hair Removal Device (IPL-001, IPL-002)
K251398 · OHT
Shenzhen Enmind Technology Co., Ltd.
General & Plastic Surgery · 149d
Cleared Oct 02, 2025
4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
K250551 · GCJ
Shenzhen Sophway Technology Co., Ltd.
General & Plastic Surgery · 219d
Cleared Oct 01, 2025
Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP,...
K252804 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 28d
Cleared Oct 01, 2025
Picosecond laser device (BMPS4)
K252447 · GEX
Hebei Newangie Technology Co., Ltd.
General & Plastic Surgery · 58d
Cleared Oct 01, 2025
Light Therapy Decollete Mask (1019135)
K252096 · OHS
Merchsource, LLC
General & Plastic Surgery · 90d
Cleared Oct 01, 2025
E Blator
K251899 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 103d
Cleared Oct 01, 2025
Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
K251825 · OHS
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 110d
Cleared Sep 30, 2025
Dexter L6 System
K251197 · SDD
Distalmotion SA
General & Plastic Surgery · 166d
Cleared Sep 29, 2025
NEW DOUBLO 2.0
K251334 · GEI
Hironic Co., Ltd.
General & Plastic Surgery · 152d
Cleared Sep 26, 2025
Magnetic Surgical System
K252435 · PNL
Levita Magnetics International Corp
General & Plastic Surgery · 56d
Cleared Sep 26, 2025
Thulium Laser System (Deluxlase)
K251919 · GEX
Nanjing Bestview Laser S&T Co., Ltd.
General & Plastic Surgery · 95d