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FDA 510(k)

iPrime Viscodelivery System

K-Number: K212797 · 2022-01-06

ApplicantGlaukos
Decision Date2022-01-06
Product CodeMRH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

iPrime Viscodelivery System is the device name listed in this FDA 510(k) record. The listed applicant is Glaukos. It received FDA 510(k) clearance on 2022-01-06 under 510(k) number K212797. The device is classified under product code MRH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iPrime Viscodelivery System?

iPrime Viscodelivery System is a medical device that received FDA 510(k) clearance on 2022-01-06. The listed applicant is Glaukos. The 510(k) number is K212797.

When did iPrime Viscodelivery System receive FDA 510(k) clearance?

iPrime Viscodelivery System received FDA 510(k) clearance on 2022-01-06, under 510(k) number K212797.

Who is the listed applicant for iPrime Viscodelivery System?

The FDA 510(k) record lists Glaukos as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iPrime Viscodelivery System?

The FDA product code for iPrime Viscodelivery System is MRH.

Related Clinical Trials

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NCT06066645Travoprost Intraocular Implant + iStent InfiniteRECRUITINGNCT07629557Evaluate the Safety and Feasibility of Same-Day Bilateral Epithelium-On Corneal Cross-Linking for KeratoconusRECRUITING

Other records listing Glaukos as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P080030Intraocular pressure lowering implantPMA P170043Intraocular pressure lowering implantK220032iStent infinite Trabecular Micro-Bypass System, Model iS3

Related Devices (Code: MRH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253760OMNI Ultra Surgical System (1-110)Sight Sciences, Inc.K243503VIA360™ Surgical SystemNew World Medical, Inc.K232214OMNI Surgical SystemSight Sciences, Inc.K213173TrabEx ProMicrosurgical Technologies, Inc.K211680Streamline Surgical SystemNew World Medical, Inc.K202678OMNI Surgical SystemSight Sciences, Inc.

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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