# K232656: BLU TOTALE (Model: ENEOB852)

- Pathway: 510(k) (Traditional)
- Applicant: Premier North America, Inc.
- Decided: Nov 14, 2023 after 75 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: 13 generations back to K943450 (1995). 99 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172555: Sapphire, Elevare Sapphire, Omm Imports, Inc. D/B/A Zero Gravity (2018) Summary page 5.

## Most influential descendants
- K250125: LMNT O2 (2025), 0 descendants of its own
- K240132: EmoLED (v. 2-USA) (2024), 0 descendants of its own

## Indications for use
BLU TOTALE is an over the counter phototherapy device for use in dermatology for the treatment of mild to moderate acne.

Source page: https://510kreport.com/device/K232656
Methodology: https://510kreport.com/methodology