Accent XL
K-Number: K160075 · 2016-08-17
ApplicantAlma Lasers, Inc.
Decision Date2016-08-17
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Accent XL is a medical device manufactured by Alma Lasers, Inc.. It received FDA 510(k) clearance on 2016-08-17 under approval number K160075. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Accent XL?
Accent XL is a medical device that received FDA 510(k) clearance on 2016-08-17. It is manufactured by Alma Lasers, Inc.. The 510(k) number is K160075.
When was Accent XL approved by the FDA?
Accent XL received FDA 510(k) clearance on 2016-08-17, under approval number K160075.
What company makes Accent XL?
Accent XL is manufactured by Alma Lasers, Inc..
What is the FDA product code for Accent XL?
The FDA product code for Accent XL is IMI.
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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.