FDA 510(k) Ophthalmic Devices
FDA 510(k) Ophthalmic Devices - Regulatory Overview
FDA 510(k) ophthalmic devices include diagnostic and surgical equipment for eye care. The FDA review panel code is OP.
Main categories:
- Contact lenses - daily, extended wear, toric and multifocal lenses
- Intraocular lenses (IOLs) - monofocal, toric and premium IOLs for cataract surgery
- Ophthalmic lasers - excimer lasers for LASIK, Nd:YAG, photocoagulation
- Retinal imaging systems - OCT, fundus cameras, fluorescein angiography
- Diagnostic instruments - tonometers, perimeters, autorefractors, slit lamps
5110
Total
5092
Cleared
168d
Avg (2y)
1976
Since
2900 Ophthalmic devices
Cleared
Dec 23, 1987
OCS 100 (OCULAR COMPARATOR SYSTEM)
HJO
Biomicroscope, Slit-lamp, Ac-powered
68d
Cleared
Dec 23, 1987
MALIS SURGICAL LOUPES
HJH
Loupe, Binocular, Low Power
29d
Cleared
Dec 23, 1987
WOODLYN CLASSIC REFRACTOR, PHOROPTOR
HKN
Refractor, Manual, Non-powered, Including Phoropter
22d
Cleared
Nov 25, 1987
BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS
LPN
Accessories, Soft Lens Products
33d
Cleared
Nov 13, 1987
KEELER CTU CRYO SYSTEM
HPS
Unit, Cryophthalmic
81d
Cleared
Nov 02, 1987
MODIFIED RETINAL CAMERA MODEL CR4-45NM
HKI
Camera, Ophthalmic, Ac-powered
31d
Cleared
Oct 15, 1987
NIDEK ADC-8000 LASER SYSTEM
HQF
Laser, Ophthalmic
87d
Cleared
Sep 29, 1987
OPTI-ZYME(R)
LPN
Accessories, Soft Lens Products
29d
Cleared
Sep 04, 1987
TROKEL SINGLE MIRROR YAG LASER LENS
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
51d
Cleared
Sep 04, 1987
18MM PEYMAN WIDE FIELD YAG LASER LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
49d
Cleared
Sep 04, 1987
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
HNF
Scissors, Ophthalmic
28d
Cleared
Aug 10, 1987
LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH
HMX
Cannula, Ophthalmic
19d
Cleared
Jul 27, 1987
IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS
HQC
Unit, Phacofragmentation
75d
Cleared
Jul 21, 1987
EYE GARD
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
56d
Cleared
Jun 19, 1987
MVS 2.5MM, 4.0MM, 6.0MM INFUSION CANNULA
HMX
Cannula, Ophthalmic
56d
Cleared
Jun 19, 1987
CANON SURGICAL AUTO KERATOMETER SK-1
HLQ
Keratoscope, Ac-powered
32d
Cleared
Jun 19, 1987
12.5MM PEYMAN WIDE FIELD YAG LASER LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
16d
Cleared
Jun 19, 1987
OPHTHALMIC CANNULA
HMX
Cannula, Ophthalmic
15d
Cleared
Jun 12, 1987
MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS
LXP
Plug, Scleral
49d
Cleared
Jun 11, 1987
SERIES TEN THOUSAND OCUTOME
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
29d
Cleared
Jun 03, 1987
25MM PEYMAN WIDE FIELD YAG LASER LENS
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
51d
Cleared
Jun 03, 1987
SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE
HQC
Unit, Phacofragmentation
49d
Cleared
May 29, 1987
BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE
HNO
Keratome, Ac-powered
91d
Cleared
May 29, 1987
SPECTACLE FRAME - DANIELLE
HQZ
Frame, Spectacle
30d
Cleared
May 29, 1987
SPECTACLE FRAME - LORRAINE
HQZ
Frame, Spectacle
30d
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