K030876 is an FDA 510(k) clearance for the CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM. This device is classified as a Massager, Therapeutic, Electric (Class I - General Controls, product code ISA).
Submitted by Cynosure, Inc. (Chelmsford, US). The FDA issued a Cleared decision on January 22, 2004, 308 days after receiving the submission on March 20, 2003.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5660.
| 510(k) Number | K030876 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2003 |
| Decision Date | January 22, 2004 |
| Days to Decision | 308 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ISA - Massager, Therapeutic, Electric |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5660 |