# K132170: Shaser V-Mini RX

- Pathway: 510(k) (Traditional)
- Applicant: Shaser, Inc.
- Decided: Nov 26, 2013 after 134 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: 1 generation back to K020856 (2002). 3 ancestors in all.
23 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130015: Shaser V-Mini Hair Removal System, Shaser, Inc. (2013) 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
- K190820: Aimanfun Lumea Comfort (2019), 22 descendants of its own
- K213558: IPL Hair Removal Device (2022), 15 descendants of its own
- K212907: Aimanfun Lumea Comfort, A-2789/A-3588 (2021), 14 descendants of its own
- K221214: Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 (2022), 12 descendants of its own
- K230739: Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 (2023), 11 descendants of its own

## Indications for use
The Shaser V-MINI 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 V-MINI 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- VI. The Shaser V-MINI RX Hair 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/K132170
Methodology: https://510kreport.com/methodology