# K121515: Isolaz 2 Intense Pulsed Light System

- Pathway: 510(k) (Special)
- Applicant: Solta Medical, Inc.
- Decided: Jun 5, 2012 after 14 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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
Longest line of descent: 12 generations back to K910422 (1992). 82 ancestors in all.
No later device cites it as a predicate yet.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083730: Isolaz, Aesthera Corporation (2009) Summary page 1.

## Indications for use
Treatment of mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).

Source page: https://510kreport.com/device/K121515
Methodology: https://510kreport.com/methodology