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
1153–1176 of 5,119
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Nov 05, 2007
NEXT GENERATION LASER
K062624 · HQF
Alcon Laboratories
Ophthalmic · 426d
Cleared Nov 05, 2007
PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
K070270 · HLJ
Kirchner & Wilhelm GmbH + Co.Kg
Ophthalmic · 280d
Cleared Nov 01, 2007
IOL INJECTOR SET
K070669 · KYB
Medicel AG
Ophthalmic · 234d
Cleared Sep 28, 2007
CA, MODEL: CAM
K071250 · OBO
Optovue, Inc.
Ophthalmic · 147d
Cleared Sep 20, 2007
LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR
K063297 · HQF
Lightmed Corp.
Ophthalmic · 323d
Cleared Aug 31, 2007
IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP
K071299 · NFJ
Digital Healthcare, Ltd.
Ophthalmic · 114d
Cleared Aug 15, 2007
BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
K071266 · HQD
Bausch & Lomb, Inc.
Ophthalmic · 100d
Cleared Aug 08, 2007
MEDPOR ATTRACTOR IMPLANT
K071335 · HPZ
Porex Surgical, Inc.
Ophthalmic · 89d
Cleared Aug 06, 2007
BENZ-G 4X HIOXIFILCON D
K062854 · LPL
Benz Research and Development Corp.
Ophthalmic · 315d
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