ENERGIST LIMITED – FDA Warning Letter, May 24, 2012

On May 21-24, 2012, an FDA inspection of Energist Limited in Swansea, UK, revealed significant violations regarding their Ultra Plus Variable Pulsed Light (VPL), iPulse i150, i200, i300 Pulsed Light Systems, and Portrait Plasma System nozzle.

The firm's devices were deemed misbranded due to failure to adequately develop, maintain, and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17). Deficiencies included lack of implementation evidence for QAP 13, inadequate definitions for reportable events, failure to stipulate 30-day reporting timelines, and incomplete information on MDR submission addresses and supplemental report requirements. Energist's responses were deemed inadequate as revised procedures still failed to meet requirements.

Additionally, the Ultra Plus VPL was marketed for "skin rejuvenation," an unapproved indication, rendering it adulterated (501(f)(1)(B)) and misbranded (502(o)) for lack of required premarket approval/clearance. The iPulse i200 and i300 Pulsed Light systems were also marketed for "treatment of acne," "hair removal," and "skin rejuvenation" without prior marketing approval or clearance, making them adulterated and misbranded.

Quality system deficiencies (21 CFR Part 820) included: 1. Failure to validate