# K070185: Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001

- Pathway: 510(k) (Traditional)
- Applicant: Pharos Life Corporation
- Decided: Aug 21, 2007 after 214 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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 K031805 (2003). 1 ancestor in all.
139 later devices descend from it; 2 cite 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)
- K031805: Blu-U, Model 4170, Dusa Pharmaceuticals, Inc. (2003) Summary page 1.

## Most influential descendants
- K080591: Tanda Skincare System, Model: Ptscs (2008), 137 descendants of its own
- K121435: Silkn Blue (2013), 125 descendants of its own
- K131461: Lightstim for Acne/ Lightstim for Acne Mini (2014), 81 descendants of its own
- K124042: Tanda Mini Skincare System (2013), 76 descendants of its own
- K162098: LED Phototherapy Device (2017), 75 descendants of its own

## Indications for use
The tinda 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/K070185
Methodology: https://510kreport.com/methodology