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FDA 510(k)

Epilaser Absolute

K-Number: K213105 · 2022-12-13

ApplicantEpilady 2000, LLC
Decision Date2022-12-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Epilaser Absolute is the device name listed in this FDA 510(k) record. The listed applicant is Epilady 2000, LLC. It received FDA 510(k) clearance on 2022-12-13 under 510(k) number K213105. 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 Epilaser Absolute?

Epilaser Absolute is a medical device that received FDA 510(k) clearance on 2022-12-13. The listed applicant is Epilady 2000, LLC. The 510(k) number is K213105.

When did Epilaser Absolute receive FDA 510(k) clearance?

Epilaser Absolute received FDA 510(k) clearance on 2022-12-13, under 510(k) number K213105.

Who is the listed applicant for Epilaser Absolute?

The FDA 510(k) record lists Epilady 2000, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Epilaser Absolute?

The FDA product code for Epilaser Absolute is GEX. This falls under the Gastroenterology category.

Other records listing Epilady 2000, 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.

K233224Epilaser ProK170970Epilaser

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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