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
May 19, 1995
CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP)
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
81d
Cleared
May 16, 1995
RYDER CONTACT LENS CASE MODEL 10670
LRX
Case, Contact Lens
61d
Cleared
May 12, 1995
NON-CONTACT TONOMETER T-2
HKX
Tonometer, Ac-powered
273d
Cleared
May 12, 1995
CRYSTAL
HQY
Sunglasses (non-prescription Including Photosensitive)
58d
Cleared
May 12, 1995
RYDER CONTACT LENS CASE
LRX
Case, Contact Lens
57d
Cleared
May 12, 1995
OTI MODEL 78-60
HJO
Biomicroscope, Slit-lamp, Ac-powered
57d
Cleared
May 12, 1995
FMS HIGH FLOW ARTHRO-SHEATH
HNX
Depressor, Orbital
30d
Cleared
May 10, 1995
VACUUM SURGE SUPRESSER
HQC
Unit, Phacofragmentation
90d
Cleared
May 10, 1995
SUNGLASSES, NONPRESCRIPTION
HQY
Sunglasses (non-prescription Including Photosensitive)
58d
Cleared
May 10, 1995
BENSON AND ASHLEY
HQY
Sunglasses (non-prescription Including Photosensitive)
44d
Cleared
May 09, 1995
FMS ARTHRO-CUTTER
HNX
Depressor, Orbital
27d
Cleared
May 08, 1995
SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE
HKY
Tonometer, Manual
179d
Cleared
May 05, 1995
THE GRIESHABER AXIAL CUTTER
HKP
Instrument, Vitreous Aspiration And Cutting, Battery-powered
119d
Cleared
May 02, 1995
BURR, CORNEAL, BATTERY-POWERED
HOG
Burr, Corneal, Battery-powered
85d
Cleared
May 02, 1995
POWER RANGERS SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
57d
Cleared
Apr 28, 1995
NONE-GENERIC
HQY
Sunglasses (non-prescription Including Photosensitive)
434d
Cleared
Apr 28, 1995
PRO-VIT
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
66d
Cleared
Apr 28, 1995
SUNNEX FASHION CORP. NON-PRESCRIPTION SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
25d
Cleared
Apr 18, 1995
NONE-GENERIC
HQY
Sunglasses (non-prescription Including Photosensitive)
424d
Cleared
Apr 18, 1995
FRINDLEY ENTERPRISE CO
HQY
Sunglasses (non-prescription Including Photosensitive)
350d
Cleared
Apr 18, 1995
INFINITECH ASPIRATING LASER PROBE
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-powered
123d
Cleared
Apr 18, 1995
SUNGLASSES
HQY
Sunglasses (non-prescription Including Photosensitive)
22d
Cleared
Apr 13, 1995
ALLURE (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
LPL
Lenses, Soft Contact, Daily Wear
330d
Cleared
Apr 11, 1995
OTI MODEL TLS-60
HPC
Set, Lens, Trial, Ophthalmic
15d
Cleared
Apr 10, 1995
LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP
HQP
Unit, Cautery, Thermal, Battery-powered
152d
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