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FDA 510(k)

VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS

K-Number: K040662 · 2004-09-08

ApplicantChattanooga Group
Decision Date2004-09-08
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Chattanooga Group. It received FDA 510(k) clearance on 2004-09-08 under 510(k) number K040662. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS?

VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS is a medical device that received FDA 510(k) clearance on 2004-09-08. The listed applicant is Chattanooga Group. The 510(k) number is K040662.

When did VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS receive FDA 510(k) clearance?

VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS received FDA 510(k) clearance on 2004-09-08, under 510(k) number K040662.

Who is the listed applicant for VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS?

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

What is the FDA product code for VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS?

The FDA product code for VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS is ILY.

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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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