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
241–264 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared CT Apr 27, 2022
Tomey Cornea/Anterior Segment OCT CASIA2
K213265 · OBO
Tomey Corporation
Ophthalmic · 209d
Cleared Apr 21, 2022
FEMTO LDV Z8 Femtosecond Surgical Laser
K213559 · OOE
Sie Ag,Surgical Instrument Engineering
Ophthalmic · 168d
Cleared Apr 19, 2022
QUATERA 700
K212241 · HQC
Carl Zeiss Meditec, AG
Ophthalmic · 274d
Cleared Mar 23, 2022
Iridex 810 Laser
K213592 · HQF
Iridex Corporation
Ophthalmic · 131d
Cleared Mar 17, 2022
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
K212631 · HQD
Contamac, Ltd.
Ophthalmic · 210d
Cleared Mar 16, 2022
iTEAR100 Neurostimulator
K213623 · QKV
Olympic Ophthalmics
Ophthalmic · 120d
Cleared Mar 01, 2022
MYAH
K211868 · MXK
Visia Imaging S.R.L.
Ophthalmic · 258d
Cleared Feb 04, 2022
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira...
K220070 · LPL
CooperVision, Inc.
Ophthalmic · 25d
Cleared Feb 02, 2022
EndoSerter-PL
K203586 · OTZ
Corneagen, Inc.
Ophthalmic · 421d
Cleared Feb 02, 2022
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses,...
K211603 · LPL
Pegavision Corporation
Ophthalmic · 254d
Cleared Jan 25, 2022
iCare HOME2
K211355 · HKY
Icare Finland OY
Ophthalmic · 267d
Cleared Jan 18, 2022
Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
K213216 · LPL
Unicon Optical Co., Ltd.
Ophthalmic · 111d
Cleared Jan 13, 2022
3N Contact Lenses Adjunct Cleaner
K211361 · LYL
Suzhou 3N Biological Technology Co.,...
Ophthalmic · 255d
Cleared Jan 07, 2022
Custom Stable Rigid Gas Permeable Scleral Contact Lens
K213880 · HQD
Valley Contax, Inc.
Ophthalmic · 25d
Cleared Jan 06, 2022
iPrime Viscodelivery System
K212797 · MRH
Glaukos
Ophthalmic · 126d
Cleared Dec 30, 2021
Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable...
K213538 · HQD
Acuity Polymers, Inc.
Ophthalmic · 52d
Cleared CT Dec 28, 2021
Alcon (serafilcon A) soft contact lenses for daily wear
K212806 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 116d
Cleared CT Dec 21, 2021
TearCare System
K213045 · ORZ
Sight Sciences, Inc.
Ophthalmic · 90d
Cleared Dec 21, 2021
DRSplus
K213705 · MYC
Centervue S.P.A.
Ophthalmic · 27d
Cleared Dec 16, 2021
Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo
K212630 · HQF
Ellex Medical Pty, Ltd.
Ophthalmic · 119d
Cleared Dec 14, 2021
ZEPTO Precision Capsulotomy System
K210827 · PUL
Centricity Vision, Inc.
Ophthalmic · 270d
Cleared Dec 06, 2021
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses,...
K211448 · LPL
Pegavision Corporation
Ophthalmic · 210d
Cleared Dec 03, 2021
Independent Corneal Viewing Chamber (IVC-21)
K211786 · LYX
Bausch & Lomb, Incorporated
Ophthalmic · 177d
Cleared Nov 29, 2021
ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)
K210930 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 245d