# K123407: Cellulaze Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Mar 29, 2013 after 144 days
- Product code: OYW (Laser, Cellulite Appearance)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Cynosure CellulazeT'l Laser is intended for the improvement in the appearance of cellulite as supported by long-term clinical data (at least 6 months with no observed reduction in treatment benefits up to 9 months of observation).

Source page: https://510kreport.com/device/K123407
Methodology: https://510kreport.com/methodology