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FDA 510(k)

PASCAL PHOTOCOAGULATOR, PASCAL-US

K-Number: K091666 · 2009-07-15

ApplicantOptimedica Corporation
Decision Date2009-07-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PASCAL PHOTOCOAGULATOR, PASCAL-US is the device name listed in this FDA 510(k) record. The listed applicant is Optimedica Corporation. It received FDA 510(k) clearance on 2009-07-15 under 510(k) number K091666. 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 PASCAL PHOTOCOAGULATOR, PASCAL-US?

PASCAL PHOTOCOAGULATOR, PASCAL-US is a medical device that received FDA 510(k) clearance on 2009-07-15. The listed applicant is Optimedica Corporation. The 510(k) number is K091666.

When did PASCAL PHOTOCOAGULATOR, PASCAL-US receive FDA 510(k) clearance?

PASCAL PHOTOCOAGULATOR, PASCAL-US received FDA 510(k) clearance on 2009-07-15, under 510(k) number K091666.

Who is the listed applicant for PASCAL PHOTOCOAGULATOR, PASCAL-US?

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 PHOTOCOAGULATOR, PASCAL-US?

The FDA product code for PASCAL PHOTOCOAGULATOR, PASCAL-US is GEX. This falls under the Gastroenterology category.

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Other records listing Optimedica Corporation as applicant

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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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