Ophthalmic

FDA medical specialty panel: Ophthalmic. Product code prefix: OP.

13 companies · 66 devices
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66 devices

Eyer Retinal Camera NM-STD (K221329)

Class Class II K221329 HKI
2023-02-22

Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) (K230228)

Class Class II K230228 HQF
2023-02-23

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (K220613)

Class Class II K220613 LPL
2023-03-08

Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens (K222954)

Class Class II K222954 LPL
2023-03-13

iExaminer System with Panoptic Plus (K223381)

Class Class II K223381 HKI
2023-03-15

Precision1, Precision1 for Astigmatism (K230785)

Class Class II K230785 LPL
2023-04-20

Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses (K221768)

Class Class II K221768 HQD
2023-05-05

Retitrack (K222484)

Class Class II K222484 HLL
2023-05-09

Ahmed® Glaucoma Valve Model FP8 (K231051)

Class Class II K231051 KYF
2023-05-12

Ahmed® Glaucoma Valve Model FP7 (K230975)

Class Class II K230975 KYF
2023-05-12

CorNeat EverPatch (K223074)

Class Class II K223074 QWU
2023-06-02

OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ (K241707)

Class Class II K241707 LPL
2024-07-12

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System (K241081)

Class Class II K241081 OBO
2024-07-17

Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) (K240169)

Class Class II K240169 HQC
2024-07-26

Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) (K242059)

Class Class II K242059 LPL
2024-08-14

BostonSight® Specialty Lenses (K241571)

Class Class II K241571 HQD
2024-08-14

BOSS™ (K223700)

Class Class II K223700 MXK
2024-08-16

VISULAS combi (K233911)

Class Class II K233911 HQF
2024-09-06

iCare ST500 (TA04) (K241447)

Class Class II K241447 HKY
2024-09-27

Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens (K242391)

Class Class II K242391 LPL
2024-10-08

CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) (K240095)

Class Class II K240095 LRX
2024-10-09

EyeGility™ Inserter for Preloaded enVista IOLs (K242389)

Class Class I K242389 MSS
2024-10-10

SPECTRALIS with Flex Module (K241163)

Class Class II K241163 OBO
2024-10-11

Digital Prism Correction Feature (DPCF) (K242058)

Class Class I K242058 SCW
2024-10-21
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