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FDA 510(k)

MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER

K-Number: K972347 · 1997-09-19

ApplicantLumenis, Inc.
Decision Date1997-09-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 1997-09-19 under 510(k) number K972347. 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 MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER?

MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER is a medical device that received FDA 510(k) clearance on 1997-09-19. The listed applicant is Lumenis, Inc.. The 510(k) number is K972347.

When did MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER receive FDA 510(k) clearance?

MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER received FDA 510(k) clearance on 1997-09-19, under 510(k) number K972347.

Who is the listed applicant for MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER?

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 MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER?

The FDA product code for MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Lumenis, Inc. as applicant

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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