Epilaser
K-Number: K170970 · 2017-09-01
ApplicantEpilady 2000, LLC
Decision Date2017-09-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Epilaser is a medical device manufactured by Epilady 2000, LLC. It received FDA 510(k) clearance on 2017-09-01 under approval number K170970. 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?
Epilaser is a medical device that received FDA 510(k) clearance on 2017-09-01. It is manufactured by Epilady 2000, LLC. The 510(k) number is K170970.
When was Epilaser approved by the FDA?
Epilaser received FDA 510(k) clearance on 2017-09-01, under approval number K170970.
What company makes Epilaser?
Epilaser is manufactured by Epilady 2000, LLC.
What is the FDA product code for Epilaser?
The FDA product code for Epilaser is GEX. This falls under the Gastroenterology category.
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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.