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
5119
Total
5101
Cleared
169d
Avg (2y)
1976
Since
5119 Ophthalmic devices
Cleared
Oct 28, 1994
CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
193d
Cleared
Oct 27, 1994
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
48d
Cleared
Oct 27, 1994
SUN EYEWEAR COMPANY, MULTIPLE BRAND NAMES
HQY
Sunglasses (non-prescription Including Photosensitive)
30d
Cleared
Oct 20, 1994
MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR
HQD
Lens, Contact (other Material) - Daily
86d
Cleared
Oct 14, 1994
ORTHOMET LHMC FEMORAL STEM
HMC
Monitor, Eye Movement, Diagnostic
556d
Cleared
Oct 13, 1994
OCU-FLEX-38 (POLYMACON)
LPL
Lenses, Soft Contact, Daily Wear
171d
Cleared
Oct 13, 1994
PHACO NEEDLES AND TIPS
HQC
Unit, Phacofragmentation
79d
Cleared
Oct 11, 1994
PHACO TIPS FOR PHACO FRAGMENTATION MACHINES
HQC
Unit, Phacofragmentation
90d
Cleared
Oct 11, 1994
RYDER CONTACT LENS CASE
LRX
Case, Contact Lens
60d
Cleared
Oct 03, 1994
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
160d
Cleared
Oct 03, 1994
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
31d
Cleared
Oct 03, 1994
TONKA BOYS SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
27d
Cleared
Oct 03, 1994
PRECISION UV(TM) (VASURFILCON A)
LPL
Lenses, Soft Contact, Daily Wear
4d
Cleared
Sep 29, 1994
AL-3300
HLM
Instrument, Measuring, Lens, Ac-powered
209d
Cleared
Sep 29, 1994
XPERT NCT
HKX
Tonometer, Ac-powered
164d
Cleared
Sep 28, 1994
AUTOMATIC LENSOMETER
HLM
Instrument, Measuring, Lens, Ac-powered
273d
Cleared
Sep 28, 1994
WIRELESS CHART PROJECTOR,HCP-W 721
HOS
Projector, Ophthalmic
273d
Cleared
Sep 28, 1994
COMPREHENSIVE PHOROPTER, MDR-680
HKN
Refractor, Manual, Non-powered, Including Phoropter
273d
Cleared
Sep 28, 1994
STANDARD PHACO TIP 15, 30, 45, 60
HQC
Unit, Phacofragmentation
264d
Cleared
Sep 28, 1994
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
205d
Cleared
Sep 28, 1994
SILHOUETTE, SUNLIMETED,ADIDAS
HQZ
Frame, Spectacle
33d
Cleared
Sep 28, 1994
SPECTACLE FRAMES
HQZ
Frame, Spectacle
21d
Cleared
Sep 23, 1994
DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS)
HJM
Transilluminator, Ac-powered
437d
Cleared
Sep 23, 1994
BIPOLAR ELECTROSURGICAL PENCIL
HQO
Unit, Cautery, Thermal, Ac-powered
88d
Cleared
Sep 21, 1994
NIL
HOI
Spectacle, Magnifying
56d
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