The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Cynosure Triactive Therapeutic Massage System.
| Device ID | K030876 |
| 510k Number | K030876 |
| Device Name: | CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM |
| Classification | Massager, Therapeutic, Electric |
| Applicant | CYNOSURE, INC. 10 ELIZABETH DR. Chelmsford, MA 01824 |
| Contact | George Cho |
| Correspondent | George Cho CYNOSURE, INC. 10 ELIZABETH DR. Chelmsford, MA 01824 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-20 |
| Decision Date | 2004-01-22 |
| Summary: | summary |