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FDA 510(k)

DERMA K ER:YAG/CO2 LASER

K-Number: K982827 · 1998-09-14

ApplicantEsc Medical Systems, Inc.
Decision Date1998-09-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMA K ER:YAG/CO2 LASER is the device name listed in this FDA 510(k) record. The listed applicant is Esc Medical Systems, Inc.. It received FDA 510(k) clearance on 1998-09-14 under 510(k) number K982827. 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 DERMA K ER:YAG/CO2 LASER?

DERMA K ER:YAG/CO2 LASER is a medical device that received FDA 510(k) clearance on 1998-09-14. The listed applicant is Esc Medical Systems, Inc.. The 510(k) number is K982827.

When did DERMA K ER:YAG/CO2 LASER receive FDA 510(k) clearance?

DERMA K ER:YAG/CO2 LASER received FDA 510(k) clearance on 1998-09-14, under 510(k) number K982827.

Who is the listed applicant for DERMA K ER:YAG/CO2 LASER?

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

What is the FDA product code for DERMA K ER:YAG/CO2 LASER?

The FDA product code for DERMA K ER:YAG/CO2 LASER is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Esc Medical Systems, 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.

K991628MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SAK965015TOPAZ 30 SURGICAL LASER SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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