# K150282: Shaser Skin Beauty Intense Pulsed Light System Family for Acne

- Pathway: 510(k) (Traditional)
- Applicant: Shaser, Inc.
- Decided: May 27, 2015 after 111 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: 17 generations back to K950019 (1995). 134 ancestors in all.
No later device cites it as a predicate yet.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141583: Shaser Skin Beauty Intense Pulsed Light System Family, Shaser, Inc. (2014) Summary page 4.
- K090744: CLARO, Clrs Technology Corporation (2010) Summary page 4.

## Indications for use
The Shaser Skin Beauty Intense Pulsed Light System Family for Acne is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K150282
Methodology: https://510kreport.com/methodology