# K141583: Shaser Skin Beauty Intense Pulsed Light System Family

- Pathway: 510(k) (Special)
- Applicant: Shaser, Inc.
- Decided: Jul 22, 2014 after 39 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: 16 generations back to K950019 (1995). 47 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133201: Shaser V-Mini 2 Hair Removal System, Shaser, Inc. (2014) Summary page 1.
- K140631: Lumena FH Hair Removal System, Shaser, Inc. (2014) Summary page 1.

## Most influential descendants
- K150282: Shaser Skin Beauty Intense Pulsed Light System Family for Acne (2015), 0 descendants of its own
- K142924: Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family (2015), 0 descendants of its own

## Indications for use
The Shaser Skin Beauty Intense Pulsed Light System Family is an over-the-counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Shaser Skin Beauty Intense Pulsed Light System Family is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Source page: https://510kreport.com/device/K141583
Methodology: https://510kreport.com/methodology