FDA 510(k) Ophthalmic Devices
About Ophthalmic Devices
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
5094
Total
5076
Cleared
109d
Avg days
1976
Since
146 Ophthalmic devices
Cleared
Sep 06, 2024
VISULAS combi
HQF
Laser, Ophthalmic
269d
Cleared
Aug 22, 2024
iCare ALTIUS CW
NFJ
System, Image Management, Ophthalmic
245d
Cleared
Aug 16, 2024
BOSS™
MXK
Device, Analysis, Anterior Segment
613d
Cleared
Aug 14, 2024
Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)
LPL
Lenses, Soft Contact, Daily Wear
30d
Cleared
Aug 14, 2024
BostonSight® Specialty Lenses
HQD
Lens, Contact (other Material) - Daily
75d
Cleared
Aug 08, 2024
Luminopia
QQU
Digital Therapy Device For Amblyopia
261d
Cleared
Aug 05, 2024
Midfield Light Pipe, 23ga (3269.M06-00)
MPA
Endoilluminator
265d
Cleared
Jul 26, 2024
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
HQC
Unit, Phacofragmentation
186d
Cleared
Jul 17, 2024
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)
OBO
Tomography, Optical Coherence
89d
Cleared
Jul 12, 2024
OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™
LPL
Lenses, Soft Contact, Daily Wear
29d
Cleared
Jul 01, 2024
Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
LPL
Lenses, Soft Contact, Daily Wear
132d
Cleared
Jul 01, 2024
SPECTRALIS HRA+OCT and variants
OBO
Tomography, Optical Coherence
157d
Cleared
Jun 28, 2024
Hello,eyes® BIO Plug
LZU
Plug, Punctum
57d
Cleared
Jun 27, 2024
Faros Surgical System
HQC
Unit, Phacofragmentation
268d
Not Cleared
Jun 27, 2024
FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System
QQJ
Applicator, Negative Pressure, External, Ocular
307d
Cleared
Jun 21, 2024
UNITY VCS (8065000296)
HQC
Unit, Phacofragmentation
197d
Cleared
Jun 13, 2024
VERVE
SBN
Digital Therapy Device For Convergence Insufficiency
267d
Cleared
May 31, 2024
LFR-260
SBI
Manual Refractor, 3d Display
245d
Cleared
May 17, 2024
CIRRUS™ HD-OCT Model 6000
OBO
Tomography, Optical Coherence
155d
Cleared
May 17, 2024
Kahook Dual Blade Glide (KDB Glide)
QUQ
Knife, Intraocular Pressure Lowering
781d
Cleared
May 15, 2024
CANON Fundus Camera CR-10 (CR-10)
HKI
Camera, Ophthalmic, Ac-powered
28d
Not Cleared
May 15, 2024
Notal Vision Home Optical Coherence Tomography (OCT) System
SAX
Home Monitoring Ophthalmic Optical Coherence Tomography (oct) Imaging Device
343d
Cleared
May 09, 2024
P200TE (A10700)
OBO
Tomography, Optical Coherence
182d
Cleared
May 08, 2024
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
LPL
Lenses, Soft Contact, Daily Wear
251d
Cleared
May 01, 2024
Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
HKY
Tonometer, Manual
182d
Looking for a specific ophthalmic device? Search by device name, K-number or manufacturer.
Search all Ophthalmic 510(k) devices