FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: General & Plastic Surgery ×
18,256 results
385–408 of 18,256
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Sep 19, 2025
VEGA
K242859 · GEX
Ibramed Equipamentos M?dicos
General & Plastic Surgery · 364d
Cleared Sep 15, 2025
IPL Hair Removal Device (MLY-M011)
K251914 · OHT
Miley Technology (Hebei) Co., Ltd.
General & Plastic Surgery · 84d
Cleared Sep 12, 2025
PowerKnot High Strength Sutures
K252225 · GAT
Medacta International S.A.
General & Plastic Surgery · 58d
Cleared Sep 12, 2025
LED Light Therapy Mask (2311, 2344, 2457, 2458)
K252189 · OHS
Dongguan Yanxi Technology Co., Ltd.
General & Plastic Surgery · 60d
Cleared Sep 12, 2025
Erchonia EVRL
K251843 · OLP
Erchonia Corporation
General & Plastic Surgery · 88d
Cleared Sep 11, 2025
RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
K251826 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 90d
Cleared Sep 10, 2025
da Vinci SP Surgical System (SP1098)
K251817 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Sep 10, 2025
OptiLUV Device
K250734 · PBX
Pollogen, Ltd.
General & Plastic Surgery · 183d
Cleared Sep 08, 2025
da Vinci Surgical System (IS5000)
K251227 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 140d
Cleared Sep 04, 2025
KALA MINI 2.0 (KALA-04)
K251781 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 85d
Cleared Sep 04, 2025
Intense Pulsed Light Therapy Device (MMABM-1)
K251545 · ONF
Micowey Medical Equipment (Guangxi)...
General & Plastic Surgery · 107d
Cleared Sep 04, 2025
Symani Surgical System
K251510 · SAQ
Medical Microinstruments, Inc.
General & Plastic Surgery · 111d
Cleared Sep 03, 2025
Diode laser therapy device (VADER)
K251457 · GEX
Beijing Superlaser Technology Co., Ltd.
General & Plastic Surgery · 114d
Cleared Sep 03, 2025
AGNES Ultra
K250217 · GEI
Agnes Medical Co., Ltd.
General & Plastic Surgery · 222d
Cleared Sep 03, 2025
MEDILIGHT
K231952 · ONF
Medicreations, LLC
General & Plastic Surgery · 796d
Cleared Aug 29, 2025
GLAM LED Facial Mask (TB-2386F)
K251727 · GEX
Touchbeauty Beauty & Health...
General & Plastic Surgery · 85d
Cleared Aug 29, 2025
da Vinci SP Surgical System (SP1098)
K251324 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 122d
Cleared Aug 29, 2025
Erbe ESU Model VIO® 3n with Accessories
K251108 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 140d
Cleared Aug 29, 2025
SIRIUS Endoscope System (PR-SI-1230)
K250939 · HET
Precision Robotics (Hong Kong) Limited
General & Plastic Surgery · 154d
Cleared Aug 28, 2025
da Vinci SP Firefly Imaging System
K252350 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 30d
Cleared Aug 27, 2025
KnoxFog Anti-fogging Device
K251068 · OCT
Uv One Hygienics, Inc.
General & Plastic Surgery · 142d
Cleared Aug 27, 2025
Dermalage
K243166 · FRO
Infection Elimination Solutions, LLC
General & Plastic Surgery · 331d
Cleared Aug 26, 2025
Heager Medical Laser Family (Sabrina/Adolf)
K250261 · GEX
Heager GmbH
General & Plastic Surgery · 209d
Cleared Aug 25, 2025
PRO Pen Microneedling System (6883)
K243800 · QAI
Dermalogica, LLC
General & Plastic Surgery · 257d