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
937–960 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 19, 2011
TBD
K112098 · OOE
Lensar, Inc.
Ophthalmic · 89d
Cleared Oct 17, 2011
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+...
K110951 · HQB
Alcon Research, Ltd.
Ophthalmic · 196d
Cleared Oct 13, 2011
MONARCH III IOL DELIVERY SYSTEM
K101774 · MSS
Alcon Manufacturing, Ltd.
Ophthalmic · 476d
Cleared Sep 27, 2011
AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
K111697 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 102d
Cleared Sep 20, 2011
FULL AUTO TONOMETER MODEL TX-20
K111710 · HKX
Canon Inc. -Medical Equipment Group
Ophthalmic · 92d
Cleared Sep 15, 2011
PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
K111966 · LPL
CooperVision, Inc.
Ophthalmic · 66d
Cleared Sep 15, 2011
SILICONE SPHERES
K112176 · HPZ
Oculo Plastik, Inc.
Ophthalmic · 49d
Cleared Sep 14, 2011
DIGITAL RETINAL CAMERA
K111612 · HKI
Canon, Inc.
Ophthalmic · 97d
Cleared Sep 08, 2011
FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION...
K103132 · LPL
Oculus Private Limited
Ophthalmic · 318d
Cleared Sep 08, 2011
RTVUE CAM WITH CORNEAL POWER UPGRADE
K111505 · OBO
Optovue, Inc.
Ophthalmic · 100d
Cleared Aug 30, 2011
RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
K110129 · HJO
Rightmedical Products, LLC
Ophthalmic · 224d
Cleared Aug 19, 2011
P200T
K111628 · MYC
Optos Plc.
Ophthalmic · 70d
Cleared Aug 11, 2011
PASCAL STREAMLINE 577 (WITH ACCESSORIES)
K111108 · HQF
Topcon Medical Laser Systems, Inc.
Ophthalmic · 113d
Cleared Jul 28, 2011
ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY...
K110261 · LPL
Soflex Limited
Ophthalmic · 181d
Cleared Jul 27, 2011
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
K111493 · HQB
Nidek Co., Ltd.
Ophthalmic · 57d
Cleared Jul 14, 2011
CARA
K110869 · NFJ
Diagnos, Inc.
Ophthalmic · 107d
Cleared Jul 14, 2011
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT...
K111856 · LRX
Apothecary Products, Inc.
Ophthalmic · 15d
Cleared Jul 08, 2011
RHA2020
K111531 · HLI
Annidis Health Systems Corp.
Ophthalmic · 36d
Cleared Jun 29, 2011
ASICO SOFTIP INJECTOR SYSTEM
K103495 · MSS
Asico, LLC
Ophthalmic · 212d
Cleared Jun 29, 2011
PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS
K110099 · LPL
CooperVision, Inc.
Ophthalmic · 167d
Not Cleared Jun 28, 2011
LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
DEN100017 · ORZ
Tearscience, Inc.
Ophthalmic · 323d
Cleared Jun 23, 2011
VISTA DIGITAL OPTHALMOSCOPE
K102412 · HKI
Eyequick.Llc
Ophthalmic · 303d
Cleared Jun 03, 2011
ISTAND
K103266 · HLI
Optovue, Inc.
Ophthalmic · 211d
Cleared Jun 01, 2011
UNIT, PHACOFRAGMENTATION
K103023 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 232d