# K240132: EmoLED (v. 2-USA)

- Pathway: 510(k) (Traditional)
- Applicant: Emoled, Srl
- Decided: Mar 12, 2024 after 55 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: 14 generations back to K943450 (1995). 109 ancestors in all.
No later device cites it as a predicate yet.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200659: Dermalux Tri-Wave MD, Aesthetic Technology, Ltd. (2020) Summary page 5.
- K232656: BLU TOTALE (Model: ENEOB852), Premier North America, Inc. (2023) Summary page 5.

## Indications for use
The EmoLED device is intended to provide photo therapeutic light to the body. The EmoLED device is generally indicated to treat dermatological conditions. The EmoLED device is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K240132
Methodology: https://510kreport.com/methodology