SMOOTHLIPO
Powered Laser Surgical Instrument
ELEME MEDICAL, INC.
The following data is part of a premarket notification filed by Eleme Medical, Inc. with the FDA for Smoothlipo.
Pre-market Notification Details
| Device ID | K083478 |
| 510k Number | K083478 |
| Device Name: | SMOOTHLIPO |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ELEME MEDICAL, INC. HERON COVE OFFICE PARK 10 AL PAUL LANE, SUITE 102 Merrimack, NH 03054 |
| Contact | Michail Pankratov, Md |
| Correspondent | Michail Pankratov, Md ELEME MEDICAL, INC. HERON COVE OFFICE PARK 10 AL PAUL LANE, SUITE 102 Merrimack, NH 03054 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-24 |
| Decision Date | 2009-03-17 |
| Summary: | summary |
Trademark Results [SMOOTHLIPO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMOOTHLIPO 90124805 not registered Live/Pending |
Jaime S. Schwartz MD, PC 2020-08-19 |
 SMOOTHLIPO 77357772 3599694 Dead/Cancelled |
CYNOSURE, INC. 2007-12-21 |
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