FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ophthalmic ×
5,110 results
913–936 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Dec 02, 2011
AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL
K113245 · LPL
CooperVision, Inc.
Ophthalmic · 30d
Cleared Dec 02, 2011
BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC
K113267 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Cleared Nov 30, 2011
NON-CONTACT TEAR FILM THERMOGRAGH
K111771 · HKI
United Integrated Services Co., Ltd.
Ophthalmic · 160d
Cleared Nov 22, 2011
FEMTEC LASER SYSTEM FOR CAPSULOTOMY
K110427 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 281d
Cleared Nov 21, 2011
INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
K112425 · HQC
Alcon Manufacturing, Ltd.
Ophthalmic · 90d
Cleared Nov 08, 2011
CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)
K111267 · LPL
Abbconcise Optical Group, LLC
Ophthalmic · 188d
Cleared Nov 08, 2011
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)
K113129 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 15d
Cleared Nov 07, 2011
LAMINAR FLOW PHACO TIPS
K111882 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 129d
Cleared Nov 03, 2011
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
K103547 · HQF
Lightmed Corp.
Ophthalmic · 336d
Cleared Nov 03, 2011
OPTO MITRA YELLOW LASER
K111643 · HQF
Opto Electronica SA
Ophthalmic · 143d
Cleared Nov 02, 2011
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
K110554 · HPZ
Ceramisys, Ltd.
Ophthalmic · 247d
Cleared Nov 02, 2011
SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT...
K111345 · LPL
The See Clear Company, Inc.
Ophthalmic · 173d
Cleared Nov 01, 2011
EYE-CEPT STERILE SALINE SOLUTION
K110221 · LPN
Optics Laboratory, Inc.
Ophthalmic · 280d
Cleared Oct 28, 2011
EASYSCAN MODEL 1.2
K111988 · MYC
I-Optics BV
Ophthalmic · 107d
Cleared Oct 25, 2011
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
K112192 · MVN
Bausch & Lomb, Inc.
Ophthalmic · 88d
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