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FDA 510(k)

Intraocular Pressure Tonometer EASYTON

K-Number: K190382 · 2019-12-06

ApplicantCompany Elamed
Decision Date2019-12-06
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Intraocular Pressure Tonometer EASYTON is a medical device manufactured by Company Elamed. It received FDA 510(k) clearance on 2019-12-06 under approval number K190382. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intraocular Pressure Tonometer EASYTON?

Intraocular Pressure Tonometer EASYTON is a medical device that received FDA 510(k) clearance on 2019-12-06. It is manufactured by Company Elamed. The 510(k) number is K190382.

When was Intraocular Pressure Tonometer EASYTON approved by the FDA?

Intraocular Pressure Tonometer EASYTON received FDA 510(k) clearance on 2019-12-06, under approval number K190382.

What company makes Intraocular Pressure Tonometer EASYTON?

Intraocular Pressure Tonometer EASYTON is manufactured by Company Elamed.

What is the FDA product code for Intraocular Pressure Tonometer EASYTON?

The FDA product code for Intraocular Pressure Tonometer EASYTON is HKX.

Related Clinical Trials

NCT07235592 PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group RECRUITING NCT02710916 SD-OCT Multimodal Analysis in GLaucoma COMPLETED NCT07599020 Measuring the Changes of the Intraocular Pressure After Corneal Cross Linking Using Corvis CT NOT_YET_RECRUITING NCT06822738 A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma RECRUITING NCT05523622 Comparison of Intraocular Pressure Measurement With the Novel TonoVera Device With Other Commonly Used Devices RECRUITING NCT04639947 Reliability and Reproducibility of the Eye Check Tonometer TERMINATED

Related Devices (Code: HKX)

K162067VX130 Ophthalmic Diagnostic DeviceLuneau Sas K180820Tono Vue Non-Contact TonometerCrystalvue Medical Corporation K181260MiiS Horus Scope DPT 100Medimaging Integrated Solution, Inc (Miis) K181143Keeler TonoCare TonometerKeeler Instruments, Inc. K223739VS Tabletop TonometerMedimaging Integrated Solution, Inc. K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATopcon Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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