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
97–120 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Oct 09, 2024
CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
K240095 · LRX
Shanghai Care US Medical Product Co.,...
Ophthalmic · 271d
Cleared Oct 08, 2024
Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
K242391 · LPL
Lucens Technology Co., Ltd.
Ophthalmic · 57d
Not Cleared Sep 30, 2024
OcuCool
DEN230011 · QZQ
Recensmedical, Inc.
Ophthalmic · 592d
Cleared CT Sep 27, 2024
iCare ST500 (TA04)
K241447 · HKY
Icare Finland OY
Ophthalmic · 128d
Cleared Sep 06, 2024
VISULAS combi
K233911 · HQF
Carl Zeiss Meditec, AG
Ophthalmic · 269d
Cleared Aug 22, 2024
iCare ALTIUS CW
K234076 · NFJ
Centervue S.P.A.
Ophthalmic · 245d
Cleared CT Aug 16, 2024
BOSS™
K223700 · MXK
Intelon Optics, Inc.
Ophthalmic · 613d
Cleared Aug 14, 2024
Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens...
K242059 · LPL
X-Cel Specialty Contacts, A Walman...
Ophthalmic · 30d
Cleared Aug 14, 2024
BostonSight® Specialty Lenses
K241571 · HQD
Boston Foundation For Sight, Inc....
Ophthalmic · 75d
Cleared Aug 08, 2024
Luminopia
K233720 · QQU
Luminopia, Inc.
Ophthalmic · 261d
Cleared Aug 05, 2024
Midfield Light Pipe, 23ga (3269.M06-00)
K233653 · MPA
Peregrine Surgical, LLC
Ophthalmic · 265d
Cleared Jul 26, 2024
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
K240169 · HQC
Bausch and Lomb, Incorporated
Ophthalmic · 186d
Cleared CT Jul 17, 2024
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)
K241081 · OBO
Topcon Corporation
Ophthalmic · 89d
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 CT 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