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FDA 510(k)

LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM

K-Number: K050639 · 2005-03-31

ApplicantLumenis, Inc.
Decision Date2005-03-31
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 2005-03-31 under 510(k) number K050639. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM?

LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2005-03-31. The listed applicant is Lumenis, Inc.. The 510(k) number is K050639.

When did LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM receive FDA 510(k) clearance?

LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM received FDA 510(k) clearance on 2005-03-31, under 510(k) number K050639.

Who is the listed applicant for LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM?

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

What is the FDA product code for LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM?

The FDA product code for LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM is GCJ.

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Other records listing Lumenis, Inc. as applicant

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K211979Lumenis Y&R Laser SystemK130195SCANNING LASERLINKK111213VISION ONE LASER SYSTEMK100228VERSAPULSE MODEL P20 LASER SYSTEMK091962POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200K082809ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM

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Related Devices (Code: GCJ)

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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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