The following data is part of a premarket notification filed by Eleme Medical, Inc. with the FDA for Smoothshapes System, 11318-120v, 11319-230v.
| Device ID | K100230 |
| 510k Number | K100230 |
| Device Name: | SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V |
| Classification | Massager, Vacuum, Light Induced Heating |
| Applicant | ELEME MEDICAL, INC. 10 AL PAUL LANE, SUITE 102 Merrimack, NH 03054 |
| Contact | William Mcgrail |
| Correspondent | William Mcgrail ELEME MEDICAL, INC. 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 | 2010-01-26 |
| Decision Date | 2010-04-02 |
| Summary: | summary |