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FDA 510(k)

PASCAL STREAMLINE PHOTOCOAGULATOR

K-Number: K100019 · 2010-05-04

ApplicantOptimedica Corporation
Decision Date2010-05-04
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PASCAL STREAMLINE PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Optimedica Corporation. It received FDA 510(k) clearance on 2010-05-04 under 510(k) number K100019. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASCAL STREAMLINE PHOTOCOAGULATOR?

PASCAL STREAMLINE PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 2010-05-04. The listed applicant is Optimedica Corporation. The 510(k) number is K100019.

When did PASCAL STREAMLINE PHOTOCOAGULATOR receive FDA 510(k) clearance?

PASCAL STREAMLINE PHOTOCOAGULATOR received FDA 510(k) clearance on 2010-05-04, under 510(k) number K100019.

Who is the listed applicant for PASCAL STREAMLINE PHOTOCOAGULATOR?

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 PASCAL STREAMLINE PHOTOCOAGULATOR?

The FDA product code for PASCAL STREAMLINE PHOTOCOAGULATOR is HQF.

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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 SYSTEMK113479OPTIMEDICA CATALYS PRECISION LASER SYSTEMK091666PASCAL PHOTOCOAGULATOR, PASCAL-USK081744PASCAL SYNTHESIS DELIVERY SYSTEMK062336OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE

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Related Devices (Code: HQF)

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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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