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
3985–4008 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared May 29, 1987
SOLA UV GARD(TM) SUNGLASSES
K870997 · HQY
Sola-Syntex Ophthalmics
Ophthalmic · 79d
Cleared May 29, 1987
CLASSIC 70 LENS
K871649 · HQC
Korea Asahi Optical Co., Ltd.
Ophthalmic · 30d
Cleared May 29, 1987
SPECTACLE FRAME - DANIELLE
K871688 · HQZ
Roseburg SA
Ophthalmic · 30d
Cleared May 29, 1987
SPECTACLE FRAME - LORRAINE
K871689 · HQZ
Roseburg SA
Ophthalmic · 30d
Cleared May 26, 1987
KESTREL CONTACT LENS CASE
K871714 · LPN
Applied Laboratories, Inc.
Ophthalmic · 22d
Cleared May 22, 1987
MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC
K870839 · HQF
Directed Energy, Inc.
Ophthalmic · 86d
Cleared May 22, 1987
VIDEOSCAN (TM)
K871479 · HLQ
Kera Corp.
Ophthalmic · 38d
Cleared May 18, 1987
TOPCON COMPUTERIZED TONOMETER CT-10
K871335 · HKX
Topcon Instrument Corporation of America
Ophthalmic · 45d
Cleared May 18, 1987
ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540
K871611 · HKO
Allergan Humphrey
Ophthalmic · 38d
Cleared May 18, 1987
TANNE CORNEAL CUTTING BLOCK
K871646 · HNJ
Ocular Instruments, Inc.
Ophthalmic · 20d
Cleared May 12, 1987
CONTACT LENS TWEEZERS
K871130 · KYE
S. M. C. Medi-Tech Corp.
Ophthalmic · 53d
Cleared May 07, 1987
LASER CONTACT LENSES CGA 1, CGI 1, CGP 1, CGV 1
K871245 · LQJ
Chiron Vision Corp.
Ophthalmic · 41d
Cleared May 07, 1987
SITE PERISTALTIC MODULE SYSTEM
K871375 · HQE
Site Microsurgical Systems, Inc.
Ophthalmic · 30d
Cleared May 07, 1987
KRATZ NOVA-SERT
K871440 · KYB
CooperVision, Inc.
Ophthalmic · 24d
Cleared Apr 27, 1987
SCHIRMER NYLON SUTURE LASER LENS
K871099 · LQJ
Ocular Instruments, Inc.
Ophthalmic · 39d
Cleared Apr 27, 1987
KNIFE, OPHTHALMIC
K871285 · HNN
Trueline Instruments, Inc.
Ophthalmic · 27d
Cleared Apr 27, 1987
DROP MATE
K871326
Mtr Enterprises, Ltd.
Ophthalmic · 24d
Cleared Apr 24, 1987
SURE DROP
K870905
Sheldon Eyedrop Support, Inc.
Ophthalmic · 50d
Cleared Apr 22, 1987
SPECTACLE FRAMES VARIOUS COLORS AND DESIGNS
K870179 · HQZ
Polinelli
Ophthalmic · 97d
Cleared Apr 16, 1987
SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS
K870178 · HQY
Polinelli
Ophthalmic · 91d
Cleared Apr 16, 1987
LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS
K870219 · HQY
Lem Srl.
Ophthalmic · 85d
Cleared Apr 16, 1987
LEM SPECTACLE FRAMES DIFFERENT COLORS AND DESIGNS
K870220 · HQZ
Lem Srl.
Ophthalmic · 85d
Cleared Apr 16, 1987
CAPSULECTOMER CYSTOTOME
K871365 · HNY
Noetix, Inc.
Ophthalmic · 9d
Cleared Apr 06, 1987
CONTAC CASE
K863846 · LPN
S. M. C. Medi-Tech Corp.
Ophthalmic · 187d