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: Ophthalmic ×
5,119 results
529–552 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 15, 2017
Katalyst Cyclophotocoagulation Probe
K163632 · LQJ
Katalyst Surgical, LLC
Ophthalmic · 175d
Cleared CT Jun 09, 2017
iVue
K163475 · OBO
Optovue, Inc.
Ophthalmic · 179d
Cleared Jun 06, 2017
Altomed Malhotra Platinum Segments
K170591 · MML
Altomed Limited
Ophthalmic · 98d
Cleared Jun 02, 2017
Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens
K170001 · HQD
Acuity Polymers, Inc.
Ophthalmic · 150d
Cleared CT Jun 02, 2017
Zepto
K170655 · PUL
Mynosys Cellular Devices, Inc.
Ophthalmic · 91d
Cleared Jun 02, 2017
PolyDev Soft Contact Lenses
K171157 · LPL
Polydev , Ltd.
Ophthalmic · 43d
Cleared May 31, 2017
SL 220
K162684 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 247d
Cleared May 31, 2017
Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens
K170007 · HQD
Acuity Polymers, Inc.
Ophthalmic · 148d
Cleared May 19, 2017
SLIT LAMP SL-2000
K163564 · HJO
Nidek Co., Ltd.
Ophthalmic · 151d
Cleared May 19, 2017
Catalys Precision Laser System
K170322 · OOE
Abbott Medical Optics, Inc.
Ophthalmic · 107d
Cleared May 05, 2017
LENSAR Laser System - fs 3D (LLS-fs 3D)
K170576 · OOE
Lensar, Inc.
Ophthalmic · 67d
Cleared May 03, 2017
PHAKOS Disposable Retinal Cryo Probe
K162756 · HRN
Phakos
Ophthalmic · 215d
Cleared May 02, 2017
AXIS Image Management System
K171098 · NFJ
Sonomed, Inc.
Ophthalmic · 19d
Cleared Apr 24, 2017
VX130 Ophthalmic Diagnostic Device
K162067 · HKX
Luneau Sas
Ophthalmic · 272d
Not Cleared Apr 24, 2017
Oculeve Intranasal Tear Neurostimulator Device
DEN160030 · PQJ
Oculeve, Inc.
Ophthalmic · 291d
Cleared Apr 19, 2017
Stellaris Elite vision enhancement system
K170052 · HQC
Bausch & Lomb
Ophthalmic · 104d
Cleared Apr 18, 2017
Lacriflow CL
K170247 · OKS
Kaneka Pharma America, LLC
Ophthalmic · 81d
Cleared Apr 17, 2017
Soft Plug Extended Duration 180 Canalicular Plug
K162361 · LZU
Oasis Medical, Inc.
Ophthalmic · 237d
Cleared Apr 14, 2017
CENTURION Vision System (Active SentryTM)
K161794 · HQC
Alcon Research, Ltd.
Ophthalmic · 288d
Cleared Apr 14, 2017
Marco Ultra M3, Marco Ultra M4
K162636 · HJO
Takagi Seiko Co., Ltd.
Ophthalmic · 205d
Cleared Apr 11, 2017
HAAG-STREIT FUNDUS MODULE 300
K163021 · HKI
Optomed OY
Ophthalmic · 162d
Cleared Apr 11, 2017
Bausch + Lomb Sensitive Eyes Plus Saline Solution
K170483 · LPN
Bausch & Lomb, Incorporated
Ophthalmic · 54d
Cleared Apr 06, 2017
Huvitz Imaging System
K161829 · NFJ
Huvitz Co., Ltd.
Ophthalmic · 275d
Cleared Apr 06, 2017
IOLMaster 700
K170171 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 77d