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
1153–1176 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 02, 2007
TRUEFIELD ANALYZER
K063310 · HPT
Seeing Machines Limited
Ophthalmic · 273d
Cleared Aug 02, 2007
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON...
K071043 · HQD
Bausch & Lomb, Inc.
Ophthalmic · 112d
Cleared Jul 24, 2007
EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION
K070767 · LPN
Lapis Lazuli International NV
Ophthalmic · 126d
Cleared Jul 20, 2007
ALLEGRO OCULYZER
K071183 · MXK
Wavelight AG
Ophthalmic · 81d
Cleared Jun 22, 2007
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
K063388 · OBO
Topcon Corp.
Ophthalmic · 226d
Cleared Jun 13, 2007
SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT...
K071203 · LPN
Optikem International, Inc.
Ophthalmic · 43d
Cleared Jun 07, 2007
CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
K062541 · LPL
Innova Vision, Inc.
Ophthalmic · 281d
Cleared May 23, 2007
ICARE TONOMETER TA01I
K063873 · HKY
Tiolat OY
Ophthalmic · 145d
Cleared May 07, 2007
LENSTEC LC INJECTION SYSTEM
K063802 · MSS
Lenstec, Inc.
Ophthalmic · 136d
Cleared May 01, 2007
OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
K070628 · HQD
Contamac, Ltd.
Ophthalmic · 55d
Cleared May 01, 2007
FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS...
K070637 · HQD
Paragon Vision Sciences
Ophthalmic · 55d
Cleared May 01, 2007
CONTACT LENS CASE
K071081 · LRX
Ningbo Kaida Rubber and Plastic...
Ophthalmic · 14d
Cleared Apr 25, 2007
ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION
K062332 · LPN
Altaire Pharmaceuticals, Inc.
Ophthalmic · 258d
Cleared Apr 24, 2007
ORION
K070231 · HKI
Nidek Technologies Srl
Ophthalmic · 90d
Cleared Apr 24, 2007
SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR
K070776 · HQF
Quantel Medical
Ophthalmic · 34d
Cleared Apr 19, 2007
ORBITAL RECONSTRUCTIVE IMPLANT
K070130 · HPZ
Becker & Associates Consulting, Inc.
Ophthalmic · 93d
Cleared Apr 13, 2007
STARION UNIVERSAL POWER SUPPLY
K070871 · HQO
Starion Instruments
Ophthalmic · 15d
Cleared Mar 27, 2007
MONARCH III IOL DELIVERY SYSTEM
K063155 · KYB
Alcon Manufacturing, Ltd.
Ophthalmic · 161d
Cleared Mar 27, 2007
MODIFICATION TO: OCU-FILM TIP COVER
K070534 · HKY
Reichert, Inc.
Ophthalmic · 29d
Cleared Mar 19, 2007
REPROCESSED PHACOEMULSIFICATION TIPS
K060648 · NKX
Alliance Medical Corp.
Ophthalmic · 371d
Cleared Mar 13, 2007
ELLEX SLIT LAMP, MODEL 30XL
K063352 · HJO
Takagi Seiko Co., Ltd.
Ophthalmic · 127d
Cleared Mar 12, 2007
FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B)...
K070308 · LPL
X-Cel Contacts
Ophthalmic · 39d
Cleared Mar 09, 2007
KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES
K062659 · HQP
Kirwan Surgical Products, Inc.
Ophthalmic · 183d
Cleared Mar 07, 2007
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
K063694 · KYB
Bausch & Lomb, Inc.
Ophthalmic · 84d