The following data is part of a premarket notification filed by Biocellulase, Inc. with the FDA for Smoothshapes.
| Device ID | K061603 |
| 510k Number | K061603 |
| Device Name: | SMOOTHSHAPES |
| Classification | Massager, Vacuum, Light Induced Heating |
| Applicant | BIOCELLULASE, INC. ONE APPLE HILL DRIVE SUITE 316 Natick, MA 01760 |
| Contact | Robert Nagel |
| Correspondent | Robert Nagel BIOCELLULASE, INC. ONE APPLE HILL DRIVE SUITE 316 Natick, MA 01760 |
| Product Code | NUV |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-08 |
| Decision Date | 2006-07-03 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SMOOTHSHAPES 76650103 3402272 Dead/Cancelled |
CYNOSURE, INC. 2005-11-10 |