Manufacturer
Shenzhen Leaflife Technology Co., Ltd.LeafPure-Echo (LM-LPNdA)
Shenzhen Leaflife Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K253219
- Device name
- LeafPure-Echo (LM-LPNdA)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-09-29
- Decision date
- 2025-11-25
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
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 types (Fitzpatrick skin types I-VI) with the following tattoo colors: 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 colors: red, yellow, and orange. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Intended 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.
Summary parsed at:2026-06-01 05:24:37 UTC
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