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FDA 510(k)

PHACOLASE ER: YAG LASER

K-Number: K991993 · 1999-11-17

ApplicantAesculap-Meditec GmbH
Decision Date1999-11-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHACOLASE ER: YAG LASER is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap-Meditec GmbH. It received FDA 510(k) clearance on 1999-11-17 under 510(k) number K991993. 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 PHACOLASE ER: YAG LASER?

PHACOLASE ER: YAG LASER is a medical device that received FDA 510(k) clearance on 1999-11-17. The listed applicant is Aesculap-Meditec GmbH. The 510(k) number is K991993.

When did PHACOLASE ER: YAG LASER receive FDA 510(k) clearance?

PHACOLASE ER: YAG LASER received FDA 510(k) clearance on 1999-11-17, under 510(k) number K991993.

Who is the listed applicant for PHACOLASE ER: YAG LASER?

The FDA 510(k) record lists Aesculap-Meditec GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHACOLASE ER: YAG LASER?

The FDA product code for PHACOLASE ER: YAG LASER is GEX. This falls under the Gastroenterology category.

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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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