FDA WARNING_LETTER - Syneron, Inc - August 06, 2010

On December 23, 2010, the FDA issued a Warning Letter to Syneron Inc. following an inspection from August 3-6, 2010, concerning their eMax System device. The device was deemed adulterated because Syneron lacked an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. It was also misbranded for failure to submit a 510(k) premarket notification and for not being registered or listed with the FDA.

Furthermore, the eMax System's labeling (User Manual and product brochure) was found to be misbranded under section 502(a) and 502(f)(1) of the Act. The labeling falsely claimed the device was adequate and effective for skin tightening, an unapproved indication for which adequate directions for use cannot be written.

The inspection also revealed Quality System regulation nonconformances. Syneron failed to establish adequate procedures for finished device acceptance, as their Acceptance Test Procedure (ATP) and "Final Test" form lacked sufficient detail on testing methods and required tests (21 CFR 820.80(d)). Additionally, they failed to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints, with incomplete fields found on Clinical Complaints form QA70001 (21 CFR 820.198(a)).

Syneron's August