# K133201: Shaser V-Mini 2 Hair Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Shaser, Inc.
- Decided: Feb 12, 2014 after 118 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: 14 generations back to K950019 (1995). 45 ancestors in all.
96 later devices descend from it; 2 cite it directly.
0 of 142 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.
- K132266: Shaser HRS2 RX Hair Removal System, Shaser, Inc. (2013)

## Most influential descendants
- 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
- K221002: IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04C (2022), 25 descendants of its own

## Indications for use
SHASER V-MINI 2 is 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 V-MINI 2 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/K133201
Methodology: https://510kreport.com/methodology