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
673–696 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 22, 2015
Bausch + Lomb Injector System
K151102 · MSS
Bausch & Lomb, Inc.
Ophthalmic · 28d
Cleared May 21, 2015
Retina Workplace
K150467 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 87d
Cleared May 18, 2015
HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
K142486 · HLJ
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 256d
Cleared May 07, 2015
Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case,...
K142717 · LRX
Ni Hau Industrial Co., Ltd.
Ophthalmic · 226d
Cleared May 06, 2015
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
K143434 · MSS
Abbott Medical Optics, Inc.
Ophthalmic · 156d
Cleared Apr 30, 2015
BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily...
K142820 · LPL
Abb Optical Group, LLC
Ophthalmic · 212d
Cleared Apr 30, 2015
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
K150385 · LPL
Visioneering Technologies, Inc.
Ophthalmic · 71d
Cleared Apr 29, 2015
iCase Contact Lens Case
K143351 · LRX
Novabay Pharmaceuticals, Inc.
Ophthalmic · 156d
Cleared Apr 23, 2015
BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens
K143280 · LPL
Brien Holden Vision Pty , Ltd.
Ophthalmic · 160d
Cleared Apr 15, 2015
EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft...
K150293 · LPL
I-See Vision Technology, Inc.
Ophthalmic · 68d
Cleared Apr 09, 2015
LIOLI IOL DELIVERY SYSTEM
K142056 · MSS
Ast Products, Inc.
Ophthalmic · 254d
Cleared Mar 20, 2015
LENSAR Laser System - fs 3D
K143010 · OOE
Lensar, Inc.
Ophthalmic · 151d
Cleared Mar 20, 2015
myVision Track Model 005
K143211 · HOQ
Vital Art and Science Incorporated
Ophthalmic · 130d
Cleared Mar 13, 2015
EVA,anterior machine, EVA, combined machine, EVA combined machine with...
K142877 · HQC
Dutch Ophthalmic Research Center...
Ophthalmic · 163d
Cleared Mar 12, 2015
I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear
K142766 · LPL
INTEROJO, Inc.
Ophthalmic · 168d
Cleared Mar 04, 2015
OCT-Camera
K142953 · HLI
Optomedical Technologies GmbH
Ophthalmic · 145d
Cleared Feb 27, 2015
IRIS INTELLIGENT RETINAL IMAGING SYSTEM
K141922 · NFJ
Intelligent Retinal Imaging Systems, LLC
Ophthalmic · 226d
Cleared Feb 27, 2015
LIGHTMED TRUSCAN 577
K142172 · HQF
Lightmed Corp.
Ophthalmic · 204d
Cleared Feb 24, 2015
Synergetics PHOTON EX
K143123 · MPA
Synergetics
Ophthalmic · 116d
Cleared Feb 20, 2015
FIBERION OPHTHALMIC ENDOLASER PROBE
K133019 · HQF
Emtron Elektronik VE Mekanik Sanayi...
Ophthalmic · 512d
Cleared Feb 20, 2015
Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and...
K143431 · LPL
I-Codi Co., Ltd.
Ophthalmic · 81d
Cleared Feb 13, 2015
Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic)...
K143632 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 53d
Cleared Jan 29, 2015
HEINE SIGMA 250 & HEINE SIGMA 250 M2
K142837 · HLJ
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 121d
Cleared CT Jan 26, 2015
CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE
K142284 · LPN
Alcon Laboratories, Inc.
Ophthalmic · 161d