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FDA 510(k)

ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM

K-Number: K082809 · 2008-12-18

ApplicantLumenis, Inc.
Decision Date2008-12-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACUPULSE 30 AND 40 CARBON DIOXIDE LASER 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 2008-12-18 under 510(k) number K082809. 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 ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM?

ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2008-12-18. The listed applicant is Lumenis, Inc.. The 510(k) number is K082809.

When did ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM receive FDA 510(k) clearance?

ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM received FDA 510(k) clearance on 2008-12-18, under 510(k) number K082809.

Who is the listed applicant for ACUPULSE 30 AND 40 CARBON DIOXIDE LASER 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 ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM?

The FDA product code for ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Lumenis, Inc. as applicant

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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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