LSSA (NP-200)

The LSSA (NP-200) is an ultrasonic surgical unit that fragments and emulsifies subcutaneous fatty tissues using piezoelectric vibrations for aesthetic body contouring. It is intended for use by plastic and reconstructive surgeons and orthopedic surgeons when fragmentation and aspiration of adipose tissue is desired.

The device operates at 37.5 kHz (B handpiece) and 31 kHz (F handpiece), compared to the predicate's 35–40 kHz range. It delivers 0–40W output acoustic power in continuous and pulsed modes (50% duty cycle) and offers five probe sizes (Ø0.9 to Ø3.7 mm), providing a wider range than the predicate device.

IEC 60601-1 (medical electrical equipment basic safety), IEC 60601-1-2 (electromagnetic compatibility), ISO 10993 biocompatibility standards (cytotoxicity, intracutaneous reactivity, skin sensitization, acute systemic toxicity, and pyrogen testing), and IEC 61847 (ultrasonic surgical frequency band definition).

The LSSA is substantially equivalent because it operates within the same ultrasonic surgical frequency band, maintains identical output power (0–40W) and operating modes as the predicate LipoSaver, and shares the same intended use and technological principles. Minor differences in specific frequencies and expanded probe diameter range do not alter intended use or raise new safety concerns, as confirmed by comprehensive performance testing.