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FDA 510(k)

OPTIMED GLAUCOMA PRESSURE REGULATOR

K-Number: K903462 · 1990-10-16

ApplicantOptimed, Inc.
Decision Date1990-10-16
Product CodeKYF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTIMED GLAUCOMA PRESSURE REGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Optimed, Inc.. It received FDA 510(k) clearance on 1990-10-16 under 510(k) number K903462. The device is classified under product code KYF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIMED GLAUCOMA PRESSURE REGULATOR?

OPTIMED GLAUCOMA PRESSURE REGULATOR is a medical device that received FDA 510(k) clearance on 1990-10-16. The listed applicant is Optimed, Inc.. The 510(k) number is K903462.

When did OPTIMED GLAUCOMA PRESSURE REGULATOR receive FDA 510(k) clearance?

OPTIMED GLAUCOMA PRESSURE REGULATOR received FDA 510(k) clearance on 1990-10-16, under 510(k) number K903462.

Who is the listed applicant for OPTIMED GLAUCOMA PRESSURE REGULATOR?

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

What is the FDA product code for OPTIMED GLAUCOMA PRESSURE REGULATOR?

The FDA product code for OPTIMED GLAUCOMA PRESSURE REGULATOR is KYF.

Related Clinical Trials

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.

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Other records listing Optimed, Inc. 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.

K890687ECT-100 ELECTRONIC CORNEAL TOPOGRAPHERK884867OPTIFIELD I AND II AUTOMATED PERIMETERSK883458OPTIMED ADVANTAGE

Related Devices (Code: KYF)

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.

K230975Ahmed® Glaucoma Valve Model FP7New World Medical, Inc.K231051Ahmed® Glaucoma Valve Model FP8New World Medical, Inc.K220032iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos CorporationK182518AHMED ClearPath Glaucoma Drainage DeviceNew World Medical, Inc.K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc.K161457XEN Glaucoma Treatment SystemAllergan, Inc.

Official Source

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

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