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
97–120 of 5,106
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jul 12, 2024
OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™
K241707 · LPL
Unicon Optical Co., Ltd.
Ophthalmic · 29d
Cleared Jul 01, 2024
Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K240477 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 132d
Cleared Jul 01, 2024
SPECTRALIS HRA+OCT and variants
K240221 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 157d
Cleared Jun 28, 2024
Hello,eyes® BIO Plug
K241229 · LZU
Bio Optics Co., Ltd.
Ophthalmic · 57d
Cleared Jun 27, 2024
Faros Surgical System
K233398 · HQC
Oertli Instrumente AG
Ophthalmic · 268d
Not Cleared Jun 27, 2024
FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System
DEN230055 · QQJ
Balance Ophthalmics, Inc.
Ophthalmic · 307d
Cleared Jun 21, 2024
UNITY VCS (8065000296)
K233876 · HQC
Alcon Laboratories, Inc.
Ophthalmic · 197d
Cleared Jun 13, 2024
VERVE
K232930 · SBN
Oculomotor Technologies
Ophthalmic · 267d
Cleared May 31, 2024
LFR-260
K233295 · SBI
Evolution Optiks Limited
Ophthalmic · 245d
Cleared May 17, 2024
CIRRUS™ HD-OCT Model 6000
K233933 · OBO
Carl Zeiss Meditec, Inc.
Ophthalmic · 155d
Cleared May 17, 2024
Kahook Dual Blade Glide (KDB Glide)
K220891 · QUQ
New World Medical, Inc.
Ophthalmic · 781d
Cleared May 15, 2024
CANON Fundus Camera CR-10 (CR-10)
K241049 · HKI
Canon, Inc.
Ophthalmic · 28d
Not Cleared May 15, 2024
Notal Vision Home Optical Coherence Tomography (OCT) System
DEN230043 · SAX
Notal Vision, Inc.
Ophthalmic · 343d
Cleared May 09, 2024
P200TE (A10700)
K233602 · OBO
Optos Plc.
Ophthalmic · 182d
Cleared May 08, 2024
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
K232649 · LPL
Pegavision Corporation
Ophthalmic · 251d
Cleared May 01, 2024
Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
K233516 · HKY
Reichert, Inc.
Ophthalmic · 182d
Cleared Apr 23, 2024
AEYE-DS
K240058 · PIB
Aeye Health, Inc.
Ophthalmic · 106d
Cleared Apr 17, 2024
Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft...
K240519 · LPL
Innova Vision, Inc.
Ophthalmic · 54d
Cleared Apr 10, 2024
3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
K233561 · OBO
Topcon Corporation
Ophthalmic · 156d
Cleared Apr 03, 2024
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K240618 · HQD
Acuity Polymers, Inc.
Ophthalmic · 29d
Cleared Mar 08, 2024
RESCAN 700
K233421 · OBO
Carl Zeiss Meditec, AG
Ophthalmic · 150d
Cleared Mar 08, 2024
HP-OCT (HP-OCT)
K231760 · HJO
Cylite Pty. , Ltd.
Ophthalmic · 266d
Cleared Mar 01, 2024
IMAGEnet6 Ophthalmic Data System
K232828 · NFJ
Topcon Corporation
Ophthalmic · 170d
Cleared Feb 26, 2024
Stellaris Elite vision enhancement system
K232084 · HQC
Bausch and Lomb
Ophthalmic · 228d