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FDA 510(k)

OPTIMEDICA CATALYS PRECISION LASER SYSTEM

K-Number: K113479 · 2011-12-21

ApplicantOptimedica Corporation
Decision Date2011-12-21
Product CodeOOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTIMEDICA CATALYS PRECISION LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Optimedica Corporation. It received FDA 510(k) clearance on 2011-12-21 under 510(k) number K113479. The device is classified under product code OOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIMEDICA CATALYS PRECISION LASER SYSTEM?

OPTIMEDICA CATALYS PRECISION LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-21. The listed applicant is Optimedica Corporation. The 510(k) number is K113479.

When did OPTIMEDICA CATALYS PRECISION LASER SYSTEM receive FDA 510(k) clearance?

OPTIMEDICA CATALYS PRECISION LASER SYSTEM received FDA 510(k) clearance on 2011-12-21, under 510(k) number K113479.

Who is the listed applicant for OPTIMEDICA CATALYS PRECISION LASER SYSTEM?

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

What is the FDA product code for OPTIMEDICA CATALYS PRECISION LASER SYSTEM?

The FDA product code for OPTIMEDICA CATALYS PRECISION LASER SYSTEM is OOE.

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Other records listing Optimedica Corporation 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.

K161455Catalys Precision Laser SystemK121091CATALYS PRECISION LASER SYSTEMK100019PASCAL STREAMLINE PHOTOCOAGULATORK091666PASCAL PHOTOCOAGULATOR, PASCAL-USK081744PASCAL SYNTHESIS DELIVERY SYSTEMK062336OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE

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Related Devices (Code: OOE)

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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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