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
2876 Ophthalmic devices
Cleared
May 17, 2022
CATALYS Precision Laser system
OOE
Ophthalmic Femtosecond Laser
83d
Cleared
May 13, 2022
Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
228d
Cleared
May 12, 2022
Capsulo
HQF
Laser, Ophthalmic
86d
Cleared
May 04, 2022
Vista Ophthalmics Vitrectomy Probe
MLZ
Vitrectomy, Instrument Cutter
119d
Not Cleared
May 02, 2022
Kerasave
QCW
Corneal Storage Media With Preservatives Including Anti-fungal
578d
Cleared
Apr 28, 2022
RetinAI Discovery
NFJ
System, Image Management, Ophthalmic
329d
Cleared
Apr 27, 2022
Tomey Cornea/Anterior Segment OCT CASIA2
OBO
Tomography, Optical Coherence
209d
Cleared
Apr 21, 2022
FEMTO LDV Z8 Femtosecond Surgical Laser
OOE
Ophthalmic Femtosecond Laser
168d
Cleared
Apr 19, 2022
QUATERA 700
HQC
Unit, Phacofragmentation
274d
Cleared
Mar 23, 2022
Iridex 810 Laser
HQF
Laser, Ophthalmic
131d
Cleared
Mar 17, 2022
Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
HQD
Lens, Contact (other Material) - Daily
210d
Cleared
Mar 16, 2022
iTEAR100 Neurostimulator
QKV
Electromechanical Tear Stimulator
120d
Cleared
Mar 01, 2022
MYAH
MXK
Device, Analysis, Anterior Segment
258d
Cleared
Feb 04, 2022
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
25d
Cleared
Feb 02, 2022
EndoSerter-PL
OTZ
Graft Insertion Instrument For Endothelial Keratoplasty
421d
Cleared
Feb 02, 2022
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
254d
Cleared
Jan 25, 2022
iCare HOME2
HKY
Tonometer, Manual
267d
Cleared
Jan 18, 2022
Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
111d
Cleared
Jan 13, 2022
3N Contact Lenses Adjunct Cleaner
LYL
Accessories, Solution, Ultrasonic Cleaners For Lenses
255d
Cleared
Jan 07, 2022
Custom Stable Rigid Gas Permeable Scleral Contact Lens
HQD
Lens, Contact (other Material) - Daily
25d
Cleared
Jan 06, 2022
iPrime Viscodelivery System
MRH
Pump, Infusion, Ophthalmic
126d
Cleared
Dec 30, 2021
Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
HQD
Lens, Contact (other Material) - Daily
52d
Cleared
Dec 28, 2021
Alcon (serafilcon A) soft contact lenses for daily wear
LPL
Lenses, Soft Contact, Daily Wear
116d
Cleared
Dec 21, 2021
TearCare System
ORZ
Eyelid Thermal Pulsation System
90d
Cleared
Dec 21, 2021
DRSplus
MYC
Ophthalmoscope, Laser, Scanning
27d
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