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FDA 510(k)

ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY

K-Number: K853878 · 1986-05-02

ApplicantEndo Lase, Inc.
Decision Date1986-05-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY is the device name listed in this FDA 510(k) record. The listed applicant is Endo Lase, Inc.. It received FDA 510(k) clearance on 1986-05-02 under 510(k) number K853878. 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 ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY?

ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY is a medical device that received FDA 510(k) clearance on 1986-05-02. The listed applicant is Endo Lase, Inc.. The 510(k) number is K853878.

When did ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY receive FDA 510(k) clearance?

ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY received FDA 510(k) clearance on 1986-05-02, under 510(k) number K853878.

Who is the listed applicant for ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY?

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

What is the FDA product code for ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY?

The FDA product code for ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY is GEX. This falls under the Gastroenterology category.

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Other records listing Endo Lase, 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.

K853900ENDO-LASE CD40 FOR NEUROSURGERYK853903ENDO-LASE CD40 CO2 FOR GYNECOLOGYK855093MEDILAS 2 ND:YAG LASER SURGERY SYSTEMK853876ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGYK853901ENDO-LASE CD 40 FOR DERMATOLOGYK853877ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY

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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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