# K124042: Tanda Mini Skincare System

- Pathway: 510(k) (Special)
- Applicant: Syneron Beauty
- Decided: Apr 2, 2013 after 95 days
- Product code: OLP (Over-The-Counter Powered Light Based Laser For Acne)
- 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: 3 generations back to K982082 (1998). 7 ancestors in all.
76 later devices descend from it; 7 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080591: Tanda Skincare System, Model: Ptscs, Pharos Life Corporation (2008) Summary page 1.

## Most influential descendants
- K160691: Acne Light Therapy Wand (2016), 50 descendants of its own
- K153081: Clear Bi-Light (2016), 46 descendants of its own
- K210948: Omnilux CLEAR (2021), 39 descendants of its own
- K213184: MZ Skin LightMAX Supercharged LED Mask 2.0 (2021), 35 descendants of its own
- K180447: reVive Light Therapy LED Cleansing System (2018), 35 descendants of its own

## Indications for use
The Tanda Mini Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K124042
Methodology: https://510kreport.com/methodology