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
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
Cleared
Aug 23, 2021
CLAREON MONARCH IV IOL Delivery System
MSS
Folders And Injectors, Intraocular Lens (iol)
54d
Cleared
Aug 20, 2021
Nam illumination probe with chopper
MPA
Endoilluminator
340d
Cleared
Aug 19, 2021
EIDON FA, EIDON, EIDON AF, EIDON UWFL
MYC
Ophthalmoscope, Laser, Scanning
108d
Cleared
Jul 26, 2021
Vision Monitor - MonpackONE
GWE
Stimulator, Photic, Evoked Response
60d
Cleared
Jul 14, 2021
Myopia Master
MXK
Device, Analysis, Anterior Segment
287d
Cleared
Jun 15, 2021
CellChek 20 rc
NFJ
System, Image Management, Ophthalmic
224d
Cleared
Jun 14, 2021
CATS®-D Tonometer Prism
HKY
Tonometer, Manual
165d
Cleared
Jun 11, 2021
Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants
NCB
Weights, Eyelid, Implantable
186d
Cleared
Jun 10, 2021
IDx-DR
PIB
Diabetic Retinopathy Detection Device
181d
Cleared
May 28, 2021
ABT12 multi-purpose solution
LPN
Accessories, Soft Lens Products
241d
Cleared
May 26, 2021
OTE MPS 045 Multi-purpose Lens Care Solution
LPN
Accessories, Soft Lens Products
138d
Cleared
May 24, 2021
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
LPL
Lenses, Soft Contact, Daily Wear
53d
Cleared
May 11, 2021
Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)
HQD
Lens, Contact (other Material) - Daily
225d
Cleared
Apr 27, 2021
AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
57d
Cleared
Apr 26, 2021
MicroDose Injector
FMF
Syringe, Piston
172d
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