# K111454: Iluminage Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Jul 5, 2012 after 407 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cynosure Affirm DO Diode Laser: named in the summary without a submission number

## Most influential descendants
- K130459: Tria Fan System (2013), 1 descendant of its own
- K141868: Tria Fanp (2014), 0 descendants of its own
- K133473: Iluminage Skin Smoothing Laser (2014), 0 descendants of its own

## Indications for use
The Iluminage laser device is indicated for use in the treatment of periorbital and perioral wrinkles.

Source page: https://510kreport.com/device/K111454
Methodology: https://510kreport.com/methodology