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510(k) K213534

PHantom Trilogy by Resurgeonz, LLC — Product Code OLI

K213534 is an FDA 510(k) premarket notification submitted by Resurgeonz, LLC for the device "PHantom Trilogy". The FDA issued a decision of Substantially Equivalent on March 11, 2022. The device falls under product code OLI (Fat Reducing Low Level Laser), a Class II device regulated under 21 CFR 878.5400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2022
Date Received
November 5, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fat Reducing Low Level Laser
Device Class
Class II
Regulation Number
878.5400
Review Panel
SU
Submission Type

Non-invasive reduction in fat layer for body contouring

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FDA data resources