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FDA 510(k)

PICASSO/ PICASSO LITE/ PICASSO PERIO

K-Number: K102359 · 2011-09-16

ApplicantAmd Lasers, LLC
Decision Date2011-09-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PICASSO/ PICASSO LITE/ PICASSO PERIO 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 2011-09-16 under 510(k) number K102359. 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/ PICASSO LITE/ PICASSO PERIO?

PICASSO/ PICASSO LITE/ PICASSO PERIO is a medical device that received FDA 510(k) clearance on 2011-09-16. The listed applicant is Amd Lasers, LLC. The 510(k) number is K102359.

When did PICASSO/ PICASSO LITE/ PICASSO PERIO receive FDA 510(k) clearance?

PICASSO/ PICASSO LITE/ PICASSO PERIO received FDA 510(k) clearance on 2011-09-16, under 510(k) number K102359.

Who is the listed applicant for PICASSO/ PICASSO LITE/ PICASSO PERIO?

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/ PICASSO LITE/ PICASSO PERIO?

The FDA product code for PICASSO/ PICASSO LITE/ PICASSO PERIO 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.

K083142PICASSO 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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