# K031805: Blu-U, Model 4170

- Pathway: 510(k) (Traditional)
- Applicant: Dusa Pharmaceuticals, Inc.
- Decided: Sep 9, 2003 after 90 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
No predicates in its family tree.
185 later devices descend from it; 6 cite it directly.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ClearLight Phototherapy Device, Model CL-420: named in the summary without a submission number

## Most influential descendants
- K070185: Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001 (2007), 139 descendants of its own
- 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

## Indications for use
The BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170 is intended to provide phototherapeutic light to the body. The BLU-U® is generally indicated to treat dermatological indications. The BLU-U® is specifically indicated to treat moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K031805
Methodology: https://510kreport.com/methodology