Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General & Plastic Surgery ×
18,368 results
529–552 of 18,368
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Aug 15, 2025
Helios Dermal Scaffold
K250397 · KGN
Helios Biomedical, Inc.
General & Plastic Surgery · 184d
Cleared Aug 14, 2025
IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A,...
K251176 · OHT
Shenzhen Mlay Intelligent Technology...
General & Plastic Surgery · 120d
Cleared Aug 14, 2025
TRUDERMAL Pro (ZLD-390)
K251012 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 134d
Cleared Aug 14, 2025
WinForth (LM-E470KA)
K250916 · PBX
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 140d
Cleared Aug 14, 2025
Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm...
K250898 · NLQ
Stryker Sustainability Solutions
General & Plastic Surgery · 142d
Cleared Aug 13, 2025
HS Fiber
K252201 · GAT
Riverpoint Medical
General & Plastic Surgery · 30d
Cleared Aug 13, 2025
DOLORCLAST Focused Shock Waves
K243279 · PZL
E.M.S Electro Medical Systems S.A
General & Plastic Surgery · 301d
Cleared Aug 12, 2025
HOTWIRE™ System RF Generator and Footswitch (optional accessory)
K252083 · GEI
Atraverse Medical, Inc.
General & Plastic Surgery · 41d
Cleared Aug 11, 2025
Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH)
K252211 · GEI
Cnc Technologies
General & Plastic Surgery · 27d
Cleared Aug 11, 2025
XERF
K251327 · GEI
Lutronic Corporation
General & Plastic Surgery · 103d
Cleared Aug 11, 2025
UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
K250462 · FET
Univlabs Technologies Private Limited
General & Plastic Surgery · 174d
Cleared Aug 08, 2025
Diode laser device (BM091)
K251801 · GEX
Hebei Newangie Technology Co., Ltd.
General & Plastic Surgery · 57d
Cleared CT Aug 08, 2025
swiftPro System (SWF-SPS)
K250718 · NEY
Emblation Limited
General & Plastic Surgery · 151d
Cleared Aug 07, 2025
LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)
K251667 · OHS
Shenzhen Liyoutong Technology Co., Ltd.
General & Plastic Surgery · 69d
Cleared Aug 06, 2025
Olo
K251432 · GEX
El.En S.P.A.
General & Plastic Surgery · 90d
Cleared Aug 06, 2025
Viction Disposable Irrigation and suction System (VC-FLA0514
K250130 · GCJ
Hangzhou Viction Medical Technology...
General & Plastic Surgery · 201d
Cleared Aug 06, 2025
Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523,...
K250124 · GCJ
Hangzhou Viction Medical Technology...
General & Plastic Surgery · 201d
Cleared Aug 04, 2025
CUTIVA™ Topical Skin Adhesive (RM1700)
K250950 · MPN
Okapi Medical, LLC Dba Resivant Medical
General & Plastic Surgery · 129d
Cleared Aug 01, 2025
IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
K251707 · OHT
Shenzhen Huachuangtong Industrial...
General & Plastic Surgery · 59d
Cleared Aug 01, 2025
Self-Forming Magnet (Flexagon Plus OTOLoc)
K250541 · SAH
GI Windows, Inc.
General & Plastic Surgery · 158d
Cleared Jul 31, 2025
eCO2 3D
K244060 · ONG
Lutronic Corporation
General & Plastic Surgery · 212d
Cleared Jul 30, 2025
Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)
K251076 · GEX
Shenzhen Lifotronic Technology Co., Ltd.
General & Plastic Surgery · 113d
Cleared Jul 29, 2025
da Vinci Surgical System, IS5000
K250442 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 165d
Cleared Jul 25, 2025
InbellaMAX System
K252215 · GEI
Inbella Medical , Ltd.
General & Plastic Surgery · 10d