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FDA 510(k)

VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM

K-Number: K070296 · 2007-10-03

ApplicantAce Vision Group
Decision Date2007-10-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ace Vision Group. It received FDA 510(k) clearance on 2007-10-03 under 510(k) number K070296. 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 VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM?

VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2007-10-03. The listed applicant is Ace Vision Group. The 510(k) number is K070296.

When did VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM receive FDA 510(k) clearance?

VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM received FDA 510(k) clearance on 2007-10-03, under 510(k) number K070296.

Who is the listed applicant for VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM?

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

What is the FDA product code for VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM?

The FDA product code for VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM 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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