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FDA 510(k)

DERMABLATE ER: YAG LASER SYSTEM

K-Number: K980361 · 1998-04-21

ApplicantAesculap-Meditec North America
Decision Date1998-04-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMABLATE ER: YAG LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap-Meditec North America. It received FDA 510(k) clearance on 1998-04-21 under 510(k) number K980361. 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 DERMABLATE ER: YAG LASER SYSTEM?

DERMABLATE ER: YAG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-21. The listed applicant is Aesculap-Meditec North America. The 510(k) number is K980361.

When did DERMABLATE ER: YAG LASER SYSTEM receive FDA 510(k) clearance?

DERMABLATE ER: YAG LASER SYSTEM received FDA 510(k) clearance on 1998-04-21, under 510(k) number K980361.

Who is the listed applicant for DERMABLATE ER: YAG LASER SYSTEM?

The FDA 510(k) record lists Aesculap-Meditec North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMABLATE ER: YAG LASER SYSTEM?

The FDA product code for DERMABLATE ER: YAG LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Aesculap-Meditec North America 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.

K994116LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)K992707MCL 29 DERMABLATE ER:YAG LASER SYSTEMK991285LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODEK981196MEDITEC LINKK974467AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08

Related Devices (Code: GEX)

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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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