The following data is part of a premarket notification filed by Resurgeonz Llc with the FDA for Phantom Trilogy.
Device ID | K213534 |
510k Number | K213534 |
Device Name: | PHantom Trilogy |
Classification | Fat Reducing Low Level Laser |
Applicant | Resurgeonz LLC 1550 Monte Carlo Court Merritt Island, FL 32952 |
Contact | Julie Lalonde |
Correspondent | Julie Lalonde Resurgeonz LLC 1550 Monte Carlo Court Merritt Island, FL 32952 |
Product Code | OLI |
CFR Regulation Number | 878.5400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-11-05 |
Decision Date | 2022-03-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PHANTOM TRILOGY 90333030 not registered Live/Pending |
Resurgeonz, LLC 2020-11-20 |