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FDA 510(k)

PL-1 Skin Treatment System

K-Number: K213726 · 2022-06-28

ApplicantAVAVA, Inc.
Decision Date2022-06-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PL-1 Skin Treatment System is a medical device manufactured by AVAVA, Inc.. It received FDA 510(k) clearance on 2022-06-28 under approval number K213726. 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 PL-1 Skin Treatment System?

PL-1 Skin Treatment System is a medical device that received FDA 510(k) clearance on 2022-06-28. It is manufactured by AVAVA, Inc.. The 510(k) number is K213726.

When was PL-1 Skin Treatment System approved by the FDA?

PL-1 Skin Treatment System received FDA 510(k) clearance on 2022-06-28, under approval number K213726.

What company makes PL-1 Skin Treatment System?

PL-1 Skin Treatment System is manufactured by AVAVA, Inc..

What is the FDA product code for PL-1 Skin Treatment System?

The FDA product code for PL-1 Skin Treatment System is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

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Other Devices by AVAVA, Inc.

K202884SR-1 Skin Treatment System K221268SR-1 Skin Treatment System K223871Miria Skin Treatment System K252155AVAVA™ Skin Treatment System K250402AVAVA™ Skin Treatment System

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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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