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
2904 Ophthalmic devices
Cleared
May 09, 1984
OPHTHALMIC CURETTE-VARIOUS
HNZ
Curette, Ophthalmic
61d
Cleared
May 09, 1984
REPLACE-A-TIP RECHARG. LOW TEMP.
HQP
Unit, Cautery, Thermal, Battery-powered
37d
Cleared
May 09, 1984
REPLACE-A-TIP RECHARGEABLE HIGH TEMP
HQP
Unit, Cautery, Thermal, Battery-powered
37d
Cleared
Apr 25, 1984
MONITOR CO2 LASER SURGICAL SYSTEM
HQF
Laser, Ophthalmic
103d
Cleared
Apr 23, 1984
ELMED WMC 10 AND BC 50 M/M
265d
Cleared
Apr 23, 1984
SURG A STAT FINE TIP 5
77d
Cleared
Apr 13, 1984
SUN-LITE ONE MILLIMETER
73d
Cleared
Apr 13, 1984
SUN-LITE 1
71d
Cleared
Apr 05, 1984
IOCARE IRRIGATION & ASPIRATION PACK
HQC
Unit, Phacofragmentation
115d
Cleared
Apr 02, 1984
MEDICAL LASER ENDOCOAGULATOR 5K
HQF
Laser, Ophthalmic
38d
Cleared
Mar 29, 1984
DOUBLE & SINGLE TANTALUM CLIPS
HQW
Clip, Tantalum, Ophthalmic
70d
Cleared
Mar 19, 1984
OPHTEC RUST RING REMOVER
HOG
Burr, Corneal, Battery-powered
97d
Cleared
Mar 16, 1984
ARGON/KRYPTON ION LASER PHOTOCOAGULA
HQF
Laser, Ophthalmic
109d
Cleared
Mar 16, 1984
MICRO FORCEPS
HNR
Forceps, Ophthalmic
94d
Cleared
Mar 16, 1984
EYE SPONGE OR SPEAR
HOZ
Sponge, Ophthalmic
94d
Cleared
Mar 16, 1984
MICRO VIT FRAGMENTATION SYSTEM
HQC
Unit, Phacofragmentation
98d
Cleared
Mar 16, 1984
CATEGORY 6 OPTHALMIC DEVICES
HOB
Clamp, Muscle, Ophthalmic
52d
Cleared
Mar 16, 1984
NEONATE MASK FOR BABIES
HOY
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
44d
Cleared
Mar 16, 1984
EYE SPEAR
HOZ
Sponge, Ophthalmic
42d
Cleared
Mar 15, 1984
DISPOSABLE FIBER OPTIC ILLUMINATOR
HQC
Unit, Phacofragmentation
162d
Cleared
Mar 12, 1984
I/A PLUS PAK SURGICAL SYSTEM
HQC
Unit, Phacofragmentation
117d
Cleared
Mar 12, 1984
KPE PLUS-PAK SURGICAL SYSTEM
HQC
Unit, Phacofragmentation
117d
Cleared
Mar 06, 1984
LASER MIRROR
Cleared
Mar 05, 1984
DISPOS. I/A & IRRIGATION HANDPIECES
HQC
Unit, Phacofragmentation
129d
Cleared
Mar 05, 1984
JAKOBI SURG. INSTRUMENTS #6 50
HKY
Tonometer, Manual
105d
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