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FDA 510(k)

OPTILITE IX LASER SURGERY ACCESSORIES

K-Number: K992866 · 1999-11-18

ApplicantConvergent Laser Technologies
Decision Date1999-11-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTILITE IX LASER SURGERY ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Convergent Laser Technologies. It received FDA 510(k) clearance on 1999-11-18 under 510(k) number K992866. 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 OPTILITE IX LASER SURGERY ACCESSORIES?

OPTILITE IX LASER SURGERY ACCESSORIES is a medical device that received FDA 510(k) clearance on 1999-11-18. The listed applicant is Convergent Laser Technologies. The 510(k) number is K992866.

When did OPTILITE IX LASER SURGERY ACCESSORIES receive FDA 510(k) clearance?

OPTILITE IX LASER SURGERY ACCESSORIES received FDA 510(k) clearance on 1999-11-18, under 510(k) number K992866.

Who is the listed applicant for OPTILITE IX LASER SURGERY ACCESSORIES?

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

What is the FDA product code for OPTILITE IX LASER SURGERY ACCESSORIES?

The FDA product code for OPTILITE IX LASER SURGERY ACCESSORIES is GEX. This falls under the Gastroenterology category.

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Other records listing Convergent Laser Technologies as applicant

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Related Devices (Code: GEX)

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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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