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
1441–1464 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Feb 20, 2003
LUNEAU STERILE TONOMETER SEPARATION PRISMS
K023838 · HKY
Luneau SA
Ophthalmic · 94d
Cleared Feb 14, 2003
CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR...
K024045 · LPL
Contamac, Ltd.
Ophthalmic · 70d
Cleared Feb 12, 2003
COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A)...
K024164 · HQD
Metro Optics, Inc.
Ophthalmic · 57d
Cleared Feb 05, 2003
GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT...
K024003 · LPL
Gelflex
Ophthalmic · 63d
Cleared Jan 27, 2003
LID CHAIN EYELID WEIGHTS
K021750 · MML
Jedmed Instrument Co.
Ophthalmic · 244d
Cleared Jan 24, 2003
MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
K030179 · NKX
Surgical Instruments Service and...
Ophthalmic · 7d
Cleared Jan 22, 2003
ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV...
K024177 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 35d
Cleared Jan 10, 2003
NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT...
K023791 · LPL
Softfocal Company, Inc.
Ophthalmic · 58d
Cleared Jan 08, 2003
MICROVISION SCLERAL BUCKLING COMPONENTS
K023481 · HQX
Microvision, Inc.
Ophthalmic · 83d
Cleared Dec 26, 2002
MASTEL 1 FOLDER IMPLANTATION SYSTEM
K022723 · KYB
Mastel Precision, Inc.
Ophthalmic · 132d
Cleared Dec 24, 2002
CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR...
K023349 · LPL
Contamac, Ltd.
Ophthalmic · 78d
Cleared Dec 23, 2002
MP-1 MICRO PERIMETER
K023719 · HKI
Nidek Technologies Srl
Ophthalmic · 48d
Cleared Dec 17, 2002
IRIDIS OPHTHALMIC PHOTOCOAGULATOR
K023094 · HQF
Quantel Medical
Ophthalmic · 90d
Cleared Dec 16, 2002
KERATOME BLADE 200200 & 600600
K020482 · HNO
Micro Specialties, Inc.
Ophthalmic · 306d
Cleared Dec 16, 2002
AUTOLENS CLEANING AND DISINFECTING UNIT
K021699 · LYL
Autolens, Inc.
Ophthalmic · 208d
Cleared Dec 13, 2002
HA ORBITAL IMPLANT
K021643 · HPZ
Laboratoire Villanova
Ophthalmic · 207d
Cleared Dec 10, 2002
OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR...
K023077 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 85d
Cleared Dec 10, 2002
CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR...
K023732 · LPL
Ciba Vision Corporation
Ophthalmic · 34d
Cleared Nov 26, 2002
HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)
K023530 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 36d
Cleared Nov 26, 2002
CANON FULL AUTO TONOMETER TX-F
K023816 · HKX
Canon, Inc.-Utsunomiya Optical...
Ophthalmic · 11d
Cleared Nov 19, 2002
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
K013694 · NFJ
Nidek, Inc.
Ophthalmic · 377d
Cleared Nov 19, 2002
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K022687 · LYL
Ciba Vision Corporation
Ophthalmic · 98d
Cleared Nov 15, 2002
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
K022982 · HNO
Med-Logics, Inc.
Ophthalmic · 67d
Cleared Nov 07, 2002
FUNDUS AUTOIMAGER
K020888 · HKI
Visual Pathways, Inc.
Ophthalmic · 234d