# K253219: LeafPure-Echo (LM-LPNdA)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Leaflife Technology Co., Ltd.
- Decided: Nov 25, 2025 after 57 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 LeafPure-Echo is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows: 1064nm wavelength: Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colours: black, brown, green, blue and purple. Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. 532nm wavelength: Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colours: red, yellow and orange. Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

Source page: https://510kreport.com/device/K253219
Methodology: https://510kreport.com/methodology