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FDA 510(k)

PICASSO LASER SYSTEM

K-Number: K083142 · 2009-03-13

ApplicantAmd Lasers, LLC
Decision Date2009-03-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PICASSO LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Amd Lasers, LLC. It received FDA 510(k) clearance on 2009-03-13 under 510(k) number K083142. 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 PICASSO LASER SYSTEM?

PICASSO LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2009-03-13. The listed applicant is Amd Lasers, LLC. The 510(k) number is K083142.

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

PICASSO LASER SYSTEM received FDA 510(k) clearance on 2009-03-13, under 510(k) number K083142.

Who is the listed applicant for PICASSO LASER SYSTEM?

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

What is the FDA product code for PICASSO LASER SYSTEM?

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

Related Clinical Trials

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Other records listing Amd 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.

K102359PICASSO/ PICASSO LITE/ PICASSO PERIO

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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