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FDA 510(k)

MODEL 450XL CO2 SURGICAL LASER

K-Number: K820327 · 1982-03-08

ApplicantLumenis, Inc.
Decision Date1982-03-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 450XL CO2 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 1982-03-08 under 510(k) number K820327. 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 MODEL 450XL CO2 SURGICAL LASER?

MODEL 450XL CO2 SURGICAL LASER is a medical device that received FDA 510(k) clearance on 1982-03-08. The listed applicant is Lumenis, Inc.. The 510(k) number is K820327.

When did MODEL 450XL CO2 SURGICAL LASER receive FDA 510(k) clearance?

MODEL 450XL CO2 SURGICAL LASER received FDA 510(k) clearance on 1982-03-08, under 510(k) number K820327.

Who is the listed applicant for MODEL 450XL CO2 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 MODEL 450XL CO2 SURGICAL LASER?

The FDA product code for MODEL 450XL CO2 SURGICAL LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Lumenis, Inc. as applicant

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.

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: GEX)

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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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