SMOOTHSHAPES
Massager, Vacuum, Light Induced Heating
ELEME MEDICAL, INC.
The following data is part of a premarket notification filed by Eleme Medical, Inc. with the FDA for Smoothshapes.
Pre-market Notification Details
| Device ID | K083629 |
| 510k Number | K083629 |
| Device Name: | SMOOTHSHAPES |
| Classification | Massager, Vacuum, Light Induced Heating |
| Applicant | ELEME MEDICAL, INC. HERON COVE OFFICE PARK 10 AL PAUL LANE, SUITE 102 Merrimack, NH 03054 |
| Contact | Michail Pankratov |
| Correspondent | Michail Pankratov ELEME MEDICAL, INC. HERON COVE OFFICE PARK 10 AL PAUL LANE, SUITE 102 Merrimack, NH 03054 |
| Product Code | NUV |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-08 |
| Decision Date | 2009-02-19 |
| Summary: | summary |
Trademark Results [SMOOTHSHAPES]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMOOTHSHAPES 76650103 3402272 Dead/Cancelled |
CYNOSURE, INC. 2005-11-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.