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: Ophthalmic ×
5,106 results
265–288 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jun 10, 2021
IDx-DR
K203629 · PIB
Digital Diagnostics, Inc.
Ophthalmic · 181d
Cleared May 28, 2021
ABT12 multi-purpose solution
K202932 · LPN
Bausch & Lomb, Incorporated
Ophthalmic · 241d
Cleared May 26, 2021
OTE MPS 045 Multi-purpose Lens Care Solution
K210051 · LPN
Ote North America, LLC
Ophthalmic · 138d
Cleared May 24, 2021
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
K210975 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 53d
Cleared May 11, 2021
Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D,...
K202860 · HQD
Valley Contax, Inc.
Ophthalmic · 225d
Cleared Apr 27, 2021
AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens
K210609 · LPL
Vp Optics
Ophthalmic · 57d
Cleared Apr 26, 2021
MicroDose Injector
K203264 · FMF
Medone Surgical, Inc.
Ophthalmic · 172d
Cleared Apr 13, 2021
RetCam Envision
K203500 · HKI
Natus Medical Incorporated Dba...
Ophthalmic · 134d
Cleared Apr 13, 2021
NFC-600 Automated Portable Retinal Camera
K210197 · HKI
Crystalvue Medical Corporation
Ophthalmic · 78d
Cleared Apr 12, 2021
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal...
K210436 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 59d
Cleared Apr 09, 2021
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K203571 · HQD
Acuity Polymers, Inc.
Ophthalmic · 123d
Cleared Apr 07, 2021
CATALYS Precision Laser System
K210701 · OOE
Amo Manufacturing USA, LLC
Ophthalmic · 29d
Cleared Apr 01, 2021
Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact...
K202129 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 244d
Cleared Apr 01, 2021
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens...
K210300 · LYL
Vuesonic, LLC
Ophthalmic · 57d
Cleared Mar 12, 2021
VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and...
K203060 · HQC
Johnson & Johnson Surgical Vision, Inc.
Ophthalmic · 155d
Cleared Mar 11, 2021
Ritleng®+ and Ritleng®+ PVP
K201892 · OKS
Fci (France Chirurgie...
Ophthalmic · 246d
Cleared Mar 01, 2021
OMNI Surgical System
K202678 · MRH
Sight Sciences, Inc.
Ophthalmic · 167d
Not Cleared Feb 23, 2021
Lumenis Stellar M22
DEN200028 · QIU
Lumenis, Ltd.
Ophthalmic · 309d
Cleared Feb 02, 2021
Fundus Camera
K202097 · HKI
Huvitz Co., Ltd.
Ophthalmic · 188d
Cleared Jan 29, 2021
VX650
K202221 · HKI
Luneau Technology Operations
Ophthalmic · 176d
Cleared Dec 30, 2020
CryoTreQ
K202038 · HPS
Vitreq BV
Ophthalmic · 160d
Cleared Dec 24, 2020
Image Quality Analyzer (IQA)
K200422 · NFJ
Visionquest Biomedical, Inc.
Ophthalmic · 308d
Cleared Dec 18, 2020
LacriJet®
K201606 · OKS
Fci (France Chirurgie...
Ophthalmic · 186d
Cleared Dec 07, 2020
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens
K200618 · LPL
Visco Vision, Inc.
Ophthalmic · 273d