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
433–456 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jul 26, 2018
RxSight Insertion Device
K181401 · MSS
Rxsight, Inc.
Ophthalmic · 58d
Cleared Jul 26, 2018
eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas...
K181579 · HQD
E&E Optics, Inc.
Ophthalmic · 41d
Cleared Jul 19, 2018
Image Filing Software NAVIS-EX
K181345 · NFJ
Nidek Co., Ltd.
Ophthalmic · 59d
Cleared Jul 16, 2018
EIDON FA
K180526 · MYC
Centervue S.P.A.
Ophthalmic · 139d
Cleared Jul 16, 2018
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
K181016 · NFJ
Welch Allyn, Inc.
Ophthalmic · 90d
Cleared Jun 29, 2018
Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan...
K181232 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 51d
Cleared Jun 27, 2018
CALLISTO eye
K180858 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 86d
Cleared Jun 27, 2018
Alleye
K180895 · HOQ
Oculocare Medical AG
Ophthalmic · 83d
Cleared Jun 25, 2018
Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan...
K181230 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 47d
Cleared Jun 13, 2018
Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and...
K181050 · LPL
Qualimed Srl
Ophthalmic · 54d
Cleared Jun 08, 2018
Nexy
K180306 · HKI
Next Sight Srl
Ophthalmic · 126d
Cleared Jun 08, 2018
Avanti
K180660 · OBO
Optovue, Inc.
Ophthalmic · 86d
Cleared Jun 08, 2018
Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses
K180985 · LPL
Supervision Optimax Sdn Bhd
Ophthalmic · 56d
Cleared Jun 08, 2018
Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58...
K180988 · HQD
Acuity Polymers, Inc.
Ophthalmic · 53d
Cleared Jun 07, 2018
AT 030
K180839 · HKY
Carl Zeiss Meditec, AG
Ophthalmic · 69d
Cleared May 30, 2018
Retia 2
K180293 · MYC
Centervue S.P.A.
Ophthalmic · 118d
Cleared May 25, 2018
PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
K180402 · HQF
Topcon Medical Laser Systems, Inc.
Ophthalmic · 100d
Not Cleared May 17, 2018
TrueTear Intranasal Tear Neurostimulator
DEN170086 · QBR
Allergan
Ophthalmic · 206d
Cleared May 16, 2018
One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
K180819 · LPL
Menicon Co, Ltd.
Ophthalmic · 48d
Cleared Apr 27, 2018
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES...
K180669 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 44d
Cleared Apr 25, 2018
OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100...
K180616 · HQD
Contamac, Ltd.
Ophthalmic · 48d
Cleared Apr 20, 2018
Si-Hy (olifilcon B) color silicone hydrogel soft contact lens
K180322 · LPL
Visco Vision, Inc.
Ophthalmic · 74d
Cleared Apr 13, 2018
VisuMax Femtosecond Laser
K173371 · HNO
Carl Zeiss Meditec, Inc.
Ophthalmic · 168d
Not Cleared Apr 11, 2018
IDx-DR
DEN180001 · PIB
Idx, LLC
Ophthalmic · 89d