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FDA 510(k)

POLARIS, OPHTHALMOLOGY

K-Number: K911926 · 1991-11-07

ApplicantPfizer Laser Systems
Decision Date1991-11-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLARIS, OPHTHALMOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer Laser Systems. It received FDA 510(k) clearance on 1991-11-07 under 510(k) number K911926. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLARIS, OPHTHALMOLOGY?

POLARIS, OPHTHALMOLOGY is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is Pfizer Laser Systems. The 510(k) number is K911926.

When did POLARIS, OPHTHALMOLOGY receive FDA 510(k) clearance?

POLARIS, OPHTHALMOLOGY received FDA 510(k) clearance on 1991-11-07, under 510(k) number K911926.

Who is the listed applicant for POLARIS, OPHTHALMOLOGY?

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

What is the FDA product code for POLARIS, OPHTHALMOLOGY?

The FDA product code for POLARIS, OPHTHALMOLOGY is GEX. This falls under the Gastroenterology category.

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Other records listing Pfizer Laser Systems 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.

K911288ORIONK910826ORION YAG LASER SYSTEM OPHTHALMOLOGYK910825ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC.K912067POLARIS, GYNECOLOGY INDICATIONSK910152ORIONK912813SIRIUS

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Related Devices (Code: GEX)

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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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