# K230100: Scizer (SC1-M410)

- Pathway: 510(k) (Traditional)
- Applicant: Classys, Inc.
- Decided: Nov 3, 2023 after 294 days
- Product code: OHV (Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption)
- Device class: 2
- Regulation: 21 CFR 878.4590
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN080006 (2009). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112626: Lipsonix (R) System Model 2, Medicis Technologies Corporation (2011) Summary page 5.

## Indications for use
The SCIZER delivers high intensity focused ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue(SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. The SCIZER is specifically indicated for non-invasive waist circumference reduction.

Source page: https://510kreport.com/device/K230100
Methodology: https://510kreport.com/methodology