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
3769–3792 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Aug 04, 1988
QRK 100, QUALITATIVE RING KERATOSCOPE
K882902 · HLR
Technitex, Inc.
Ophthalmic · 23d
Cleared Aug 02, 1988
RESUBMITTED DIODE LASER COAGULATOR
K882372 · HQF
CooperVision, Inc.
Ophthalmic · 68d
Cleared Jul 29, 1988
BOLDREY PERIPHERAL RETINAL LENS
K882574 · LQJ
Ocular Instruments, Inc.
Ophthalmic · 37d
Cleared Jul 29, 1988
NEOLENS SUNGLASSES
K882813 · HQY
Neolens, Inc.
Ophthalmic · 21d
Cleared Jul 29, 1988
NEOLENS PRESCRIPTION SPECTACLE LENS
K882814 · HQG
Neolens, Inc.
Ophthalmic · 21d
Cleared Jul 22, 1988
CR-39 PLASTIC LENSES FOR EYEGLASSES
K882308 · HQG
Automated Lens System
Ophthalmic · 49d
Cleared Jul 15, 1988
VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE
K882634 · HOX
Vistech Consultants, Inc.
Ophthalmic · 18d
Cleared Jul 13, 1988
JEDMED/POLACK KERATOSCOPE HS/SL
K882618 · HLR
Gamut Ent.
Ophthalmic · 19d
Cleared Jul 08, 1988
COOL EYE(TM) EYE PROTECTOR
K881135 · HOY
Cool Eyes, Inc.
Ophthalmic · 114d
Cleared Jul 01, 1988
UNI-PORT
K880543 · KYG
Surgeon Surgical Instrumentation, Inc.
Ophthalmic · 143d
Cleared Jul 01, 1988
NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM
K881635 · HQC
Noetix, Inc.
Ophthalmic · 78d
Cleared Jul 01, 1988
ALCON SITE(R)-COMPATIBLE CASSETTE
K881682 · KYG
Alcon Laboratories
Ophthalmic · 73d
Cleared Jul 01, 1988
SITE ULTRASONIC I/A PHACO NEEDLE
K882103 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 43d
Cleared Jul 01, 1988
NIDEK ARK-2000
K882191 · HKO
Nidek, Inc.
Ophthalmic · 38d
Cleared Jul 01, 1988
CANON AUTOREFRACTOMETER R-20
K882287 · HKO
Canon USA, Inc.
Ophthalmic · 30d
Cleared Jul 01, 1988
DISTOMETER
K882575 · HMM
Hagg-Streit Service, Inc.
Ophthalmic · 9d
Cleared Jun 28, 1988
ULTRAVIOLET LIGHT PROTECTVE EYEWERE
K880666 · HOY
Free Sun Intl. AB
Ophthalmic · 131d
Cleared Jun 28, 1988
SLC HARD LENS CLEANER
K880688 · LPN
Ocular Pharmaceuticals, Inc.
Ophthalmic · 127d
Cleared Jun 27, 1988
PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM
K881358 · HOX
Neuroscientific Corp.
Ophthalmic · 88d
Cleared Jun 09, 1988
DURACLEAN DAILY CLEANER
K881987 · LPN
Allergan Optical
Ophthalmic · 29d
Cleared Jun 06, 1988
EFFNER CAUTERY INSTRUMENTS
K875260 · HQP
Effner and Spreine Co.
Ophthalmic · 167d
Cleared Jun 06, 1988
SLT CONTACT LASER SYSTEM OCULOPLASTICS
K881134 · HQF
Surgical Laser Technologies, Inc.
Ophthalmic · 82d
Cleared Jun 06, 1988
REUSABLE FIBEROPTIC LIGHTPIPE
K881926 · HQB
Advanced Surgical Products, Inc.
Ophthalmic · 28d
Cleared May 26, 1988
MICROLINE CAT #100
K880943 · HQE
Microline Pentax, Inc.
Ophthalmic · 80d