# K250125: LMNT O2

- Pathway: 510(k) (Traditional)
- Applicant: Xplr, Ltd.
- Decided: Mar 24, 2025 after 66 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- 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). 111 ancestors in all.
No later device cites it as a predicate yet.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232656: BLU TOTALE (Model: ENEOB852), Premier North America, Inc. (2023) Summary page 5.
- K181659: Avologi ENEO, Premier North America, Inc. (2018) Summary page 5.

## Indications for use
LMNT O2 is an over-the-counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. In addition, LMNT O2 indicated to emit energy in the blue region of the spectrum for use in dermatology for the treatment of mild to moderate acne.

Source page: https://510kreport.com/device/K250125
Methodology: https://510kreport.com/methodology