# K132266: Shaser HRS2 RX Hair Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Shaser, Inc.
- Decided: Sep 30, 2013 after 70 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: 13 generations back to K950019 (1995). 43 ancestors in all.
97 later devices descend from it; 1 cites it directly.
0 of 141 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120080: Shaser HRS2 Hair Removal System, Shaser, Inc. (2012) Summary page 1.
- K020856: Spatouch Photoepilation System, Radiancy (Israel), Ltd. (2002) Summary page 1.
- K051671: Radiancy Skinstation with Modified Light Unit Addembly, Radiancy (Israel), Ltd. (2005)

## Most influential descendants
- K133201: Shaser V-Mini 2 Hair Removal System (2014), 96 descendants of its own
- K140631: Lumena FH Hair Removal System (2014), 95 descendants of its own
- K181568: IPL Salon Hair Reduction System (2018), 88 descendants of its own
- K192432: IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130 (2019), 66 descendants of its own
- K212318: IPL Hair Removal (2022), 26 descendants of its own

## Indications for use
The Shaser HRS2 RX Hair Removal System is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. It is also intended for removal of unwanted hair by using a selective photothermal treatment. The Shaser HRS2 RX Hair Removal System is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Shaser HRS2 RX Hlair Removal System 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/K132266
Methodology: https://510kreport.com/methodology