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FDA 510(k)

ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA-

K-Number: K853874 · 1985-10-25

ApplicantEndo Lase, Inc.
Decision Date1985-10-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA- 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 1985-10-25 under 510(k) number K853874. 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 EXTERNAL GENITALIA-?

ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA- is a medical device that received FDA 510(k) clearance on 1985-10-25. The listed applicant is Endo Lase, Inc.. The 510(k) number is K853874.

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

ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA- received FDA 510(k) clearance on 1985-10-25, under 510(k) number K853874.

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

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 EXTERNAL GENITALIA-?

The FDA product code for ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA- 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 NEUROSURGERYK853878ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERYK855093MEDILAS 2 ND:YAG LASER SURGERY SYSTEMK853903ENDO-LASE CD40 CO2 FOR GYNECOLOGYK853876ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGYK853901ENDO-LASE CD 40 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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