# K241358: BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E

- Pathway: 510(k) (Special)
- Applicant: Sun Pharmaceutical Industries, Inc.
- Decided: Jun 13, 2024 after 30 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

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

Source page: https://510kreport.com/device/K241358
Methodology: https://510kreport.com/methodology