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
553–576 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Mar 24, 2017
Stellaris Elite Vision Enhancement System
K162342 · HQC
Bausch & Lomb
Ophthalmic · 214d
Cleared Mar 24, 2017
Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens
K170335 · HQD
Valley Contax, Inc.
Ophthalmic · 50d
Cleared Mar 22, 2017
HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit...
K170520 · MLZ
Alcon Research, Ltd.
Ophthalmic · 28d
Cleared Mar 21, 2017
Icare HOME tonometer
K163343 · HKY
Icare Finland OY
Ophthalmic · 112d
Cleared Mar 03, 2017
3D OCT-1 Maestro
K170164 · OBO
Topcon Corporation
Ophthalmic · 44d
Cleared Feb 23, 2017
VISULUX
K161607 · HJO
Carl Zeiss Meditec, AG
Ophthalmic · 258d
Cleared Feb 16, 2017
SLIT LAMP, Model: YF-100
K161764 · HJO
Chongqing Yeasn Science-Technology...
Ophthalmic · 234d
Cleared Feb 08, 2017
OptosAdvance 4.0 Software
K162039 · NFJ
Optos Plc.
Ophthalmic · 201d
Cleared Feb 03, 2017
LenSx Laser System
K163551 · OOE
Alcon Laboratories, Inc.
Ophthalmic · 46d
Cleared Jan 23, 2017
D.O.R.C. Disposable Cryo Probe
K160591 · HRN
Dutch Ophthalmic Research Center...
Ophthalmic · 328d
Cleared Jan 18, 2017
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens
K163254 · HQD
Acuity Polymers, Inc.
Ophthalmic · 58d
Cleared Jan 04, 2017
Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)
K162223 · LPL
Supervision Optimax Sdn Bhd
Ophthalmic · 149d
Cleared Dec 19, 2016
Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable...
K161739 · LPL
Pegavision Corporation
Ophthalmic · 178d
Cleared Dec 09, 2016
Slit Lamp SL-D301
K161972 · HJO
Topcon Corporation
Ophthalmic · 144d
Cleared Dec 09, 2016
EnFocus 2300, EnFocus 4400
K162783 · OBO
Bioptigen, Inc.
Ophthalmic · 67d
Cleared Dec 09, 2016
Contact Lens Case
K162869 · LRX
Ningbo Yinzhou Zonghai Artware Co., Ltd.
Ophthalmic · 57d
Cleared Dec 08, 2016
Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
K162005 · HQD
Acuity Polymers, Inc.
Ophthalmic · 141d
Cleared Nov 30, 2016
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal,...
K161391 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 195d
Cleared Nov 29, 2016
Lenstec LC Injection system
K161776 · MSS
Lenstec, Inc.
Ophthalmic · 153d
Cleared Nov 25, 2016
NNR06 Multi-Purpose Solution
K161819 · LPN
Bausch & Lomb, Incorporated
Ophthalmic · 147d
Cleared Nov 21, 2016
XEN Glaucoma Treatment System
K161457 · KYF
Allergan, Inc.
Ophthalmic · 179d
Cleared Nov 18, 2016
LacriPro Punctum Plug
K161673 · LZU
Lacrimedics, Inc.
Ophthalmic · 155d
Cleared Nov 16, 2016
LenSX Laser System
K161288 · OOE
Alcon Laboratories, Inc.
Ophthalmic · 191d
Cleared Nov 15, 2016
SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact...
K153714 · HQD
Synergeyes, Inc.
Ophthalmic · 327d