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FDA 510(k)

DERMA 20 LASER SYSTEM

K-Number: K964253 · 1997-04-11

ApplicantEsc Medical Systems , Ltd.
Decision Date1997-04-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMA 20 LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Esc Medical Systems , Ltd.. It received FDA 510(k) clearance on 1997-04-11 under 510(k) number K964253. 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 20 LASER SYSTEM?

DERMA 20 LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-11. The listed applicant is Esc Medical Systems , Ltd.. The 510(k) number is K964253.

When did DERMA 20 LASER SYSTEM receive FDA 510(k) clearance?

DERMA 20 LASER SYSTEM received FDA 510(k) clearance on 1997-04-11, under 510(k) number K964253.

Who is the listed applicant for DERMA 20 LASER SYSTEM?

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

What is the FDA product code for DERMA 20 LASER SYSTEM?

The FDA product code for DERMA 20 LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Esc Medical Systems , Ltd. as applicant

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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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