FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ophthalmic ×
5,110 results
241–264 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
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 Dec 28, 2021
Alcon (serafilcon A) soft contact lenses for daily wear
K212806 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 116d
Cleared 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
Cleared Nov 05, 2021
Anterion
K211817 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 147d
Cleared Oct 26, 2021
Avaira Vitality
K213164 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Not Cleared Oct 20, 2021
Luminopia One
DEN210005 · QQU
Luminopia, Inc.
Ophthalmic · 233d
Cleared Oct 08, 2021
Streamline Surgical System
K211680 · MRH
New World Medical, Inc.
Ophthalmic · 129d
Cleared Sep 13, 2021
Harmony Referral System
K210396 · NFJ
Topcon Healthcare Solutions EMEA Oy
Ophthalmic · 215d
Cleared Aug 23, 2021
CLAREON MONARCH IV IOL Delivery System
K212039 · MSS
Alcon Laboratories, Inc.
Ophthalmic · 54d
Cleared Aug 20, 2021
Nam illumination probe with chopper
K202670 · MPA
Oculight , Ltd.
Ophthalmic · 340d
Cleared Aug 19, 2021
EIDON FA, EIDON, EIDON AF, EIDON UWFL
K211328 · MYC
Centervue S.P.A.
Ophthalmic · 108d
Cleared Jul 26, 2021
Vision Monitor - MonpackONE
K211643 · GWE
Metrovision
Ophthalmic · 60d