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
5100
Total
5082
Cleared
170d
Avg (2y)
1976
Since
490 Ophthalmic devices
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
Cleared
Dec 16, 2021
Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo
HQF
Laser, Ophthalmic
119d
Cleared
Dec 14, 2021
ZEPTO Precision Capsulotomy System
PUL
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered
270d
Cleared
Dec 06, 2021
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
210d
Cleared
Dec 03, 2021
Independent Corneal Viewing Chamber (IVC-21)
LYX
Media, Corneal Storage
177d
Cleared
Nov 29, 2021
ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)
LPL
Lenses, Soft Contact, Daily Wear
245d
Cleared
Nov 05, 2021
Anterion
OBO
Tomography, Optical Coherence
147d
Cleared
Oct 26, 2021
Avaira Vitality
LPL
Lenses, Soft Contact, Daily Wear
28d
Not Cleared
Oct 20, 2021
Luminopia One
QQU
Digital Therapy Device For Amblyopia
233d
Cleared
Oct 08, 2021
Streamline Surgical System
MRH
Pump, Infusion, Ophthalmic
129d
Cleared
Sep 13, 2021
Harmony Referral System
NFJ
System, Image Management, Ophthalmic
215d
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