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FDA 510(k)

STYLA MICROLASER AND STYLAORTHO

K-Number: K081214 · 2008-05-14

ApplicantZap Lasers, LLC
Decision Date2008-05-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STYLA MICROLASER AND STYLAORTHO is the device name listed in this FDA 510(k) record. The listed applicant is Zap Lasers, LLC. It received FDA 510(k) clearance on 2008-05-14 under 510(k) number K081214. 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 STYLA MICROLASER AND STYLAORTHO?

STYLA MICROLASER AND STYLAORTHO is a medical device that received FDA 510(k) clearance on 2008-05-14. The listed applicant is Zap Lasers, LLC. The 510(k) number is K081214.

When did STYLA MICROLASER AND STYLAORTHO receive FDA 510(k) clearance?

STYLA MICROLASER AND STYLAORTHO received FDA 510(k) clearance on 2008-05-14, under 510(k) number K081214.

Who is the listed applicant for STYLA MICROLASER AND STYLAORTHO?

The FDA 510(k) record lists Zap Lasers, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STYLA MICROLASER AND STYLAORTHO?

The FDA product code for STYLA MICROLASER AND STYLAORTHO 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 Zap Lasers, LLC 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.

K091796SOFTLASE PRO, ORTHOLASE AND HYGIENELASEK021227SOFTLASE G2-SURGICAL DIODE 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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