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
289–312 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Apr 07, 2021
CATALYS Precision Laser System
K210701 · OOE
Amo Manufacturing USA, LLC
Ophthalmic · 29d
Cleared Apr 01, 2021
Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact...
K202129 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 244d
Cleared Apr 01, 2021
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens...
K210300 · LYL
Vuesonic, LLC
Ophthalmic · 57d
Cleared Mar 12, 2021
VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and...
K203060 · HQC
Johnson & Johnson Surgical Vision, Inc.
Ophthalmic · 155d
Cleared Mar 11, 2021
Ritleng®+ and Ritleng®+ PVP
K201892 · OKS
Fci (France Chirurgie...
Ophthalmic · 246d
Cleared Mar 01, 2021
OMNI Surgical System
K202678 · MRH
Sight Sciences, Inc.
Ophthalmic · 167d
Not Cleared Feb 23, 2021
Lumenis Stellar M22
DEN200028 · QIU
Lumenis, Ltd.
Ophthalmic · 309d
Cleared Feb 02, 2021
Fundus Camera
K202097 · HKI
Huvitz Co., Ltd.
Ophthalmic · 188d
Cleared Jan 29, 2021
VX650
K202221 · HKI
Luneau Technology Operations
Ophthalmic · 176d
Cleared Dec 30, 2020
CryoTreQ
K202038 · HPS
Vitreq BV
Ophthalmic · 160d
Cleared Dec 24, 2020
Image Quality Analyzer (IQA)
K200422 · NFJ
Visionquest Biomedical, Inc.
Ophthalmic · 308d
Cleared Dec 18, 2020
LacriJet®
K201606 · OKS
Fci (France Chirurgie...
Ophthalmic · 186d
Cleared Dec 07, 2020
HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens
K200618 · LPL
Visco Vision, Inc.
Ophthalmic · 273d
Cleared Dec 07, 2020
Ophthalmic Yag Laser System YC-200
K203130 · HQF
Nidek Co., Ltd.
Ophthalmic · 49d
Cleared Nov 20, 2020
Optomed Smartscope M5 with Optomed Smartscope FA
K201325 · HKI
Optomed Oyj
Ophthalmic · 186d
Cleared Oct 21, 2020
Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59%...
K201268 · LPL
Plexus Optix, Inc.
Ophthalmic · 162d
Cleared Oct 21, 2020
Pentacam AXL Wave
K201724 · MXK
Oculus Optikgerate GmbH
Ophthalmic · 120d
Cleared Oct 21, 2020
Iridex 810 Laser
K202760 · HQF
Iridex Corporation
Ophthalmic · 30d
Cleared Oct 20, 2020
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1...
K202756 · LPL
CooperVision, Inc.
Ophthalmic · 29d
Cleared Oct 15, 2020
xPORT S Lens Fragmentation System
K200207 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 261d
Cleared Oct 15, 2020
Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact...
K200296 · LPL
Pegavision Corporation
Ophthalmic · 252d
Cleared Sep 25, 2020
ImageSPECTRUM
K201273 · NFJ
Canon, Inc.
Ophthalmic · 136d
Not Cleared Sep 24, 2020
Tangible Boost
DEN200002 · QMM
Tangible Science, Inc.
Ophthalmic · 255d
Cleared Sep 23, 2020
Boston One Step Liquid Enzymatic Cleaner
K200416 · MRC
Bausch & Lomb, Incorporated
Ophthalmic · 216d