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
2896 Ophthalmic devices
Cleared
Apr 24, 1996
OAKLEY, INC SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
22d
Cleared
Apr 18, 1996
WHITE RIVER BATTERY-POWERED BREAST PUMP
HGX
Pump, Breast, Powered
309d
Cleared
Apr 15, 1996
D.O.R.C. VFI/VFE SYSTEM
KYG
Device, Irrigation, Ocular Surgery
175d
Cleared
Apr 11, 1996
FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
442d
Cleared
Apr 10, 1996
SUNGLASSES OR MULTIPLE
HQY
Sunglasses (non-prescription Including Photosensitive)
36d
Cleared
Apr 10, 1996
POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
35d
Cleared
Apr 10, 1996
FRANCO SORDELLI SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
30d
Cleared
Apr 10, 1996
US-HOLO SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
27d
Cleared
Apr 01, 1996
SHADOW MEDAL LOCATOR
HPM
Locator, Metal, Electronic
263d
Cleared
Mar 28, 1996
W-55 (METHAFILON A) CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
181d
Cleared
Mar 28, 1996
TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
127d
Cleared
Mar 28, 1996
STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX
HQC
Unit, Phacofragmentation
90d
Cleared
Mar 28, 1996
FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
62d
Cleared
Mar 28, 1996
SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
62d
Cleared
Mar 26, 1996
STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
MPA
Endoilluminator
84d
Cleared
Mar 25, 1996
NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR
HQD
Lens, Contact (other Material) - Daily
87d
Cleared
Mar 25, 1996
TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
63d
Cleared
Mar 21, 1996
ALCON SERIES 20000 LEGACY MACKOOL SYSTEM
HQC
Unit, Phacofragmentation
90d
Cleared
Mar 19, 1996
O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS
HQD
Lens, Contact (other Material) - Daily
200d
Cleared
Mar 19, 1996
NON PRESCRIPTION SUN GLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
78d
Cleared
Mar 12, 1996
SUNGLASSES/EYEGLASS FRAMES
HQY
Sunglasses (non-prescription Including Photosensitive)
29d
Cleared
Mar 12, 1996
FABRIS LAN SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
15d
Cleared
Mar 12, 1996
D & K SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
14d
Cleared
Mar 11, 1996
PALLIKARIS BRUSH
HOG
Burr, Corneal, Battery-powered
53d
Cleared
Mar 06, 1996
RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)
OKS
Lacrimal Stents And Intubation Sets
93d
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