Manufacturer
Smedtrum Medical Technology Co., Ltd.Picosecond Nd:YAG Laser System
Smedtrum Medical Technology Co., Ltd.
Country / Region:Taiwan (TW)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K240118
- Device name
- Picosecond Nd:YAG Laser System
- Country / Region
- Taiwan(TW)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-01-16
- Decision date
- 2024-04-30
- 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 Picosecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery: such as tattoos removal and benign pigmented lesions. 1064nm wavelength: - Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, blue, green 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 Picosecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery: such as tattoos removal and benign pigmented lesions. 1064nm wavelength: - Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, blue, green 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.
Device Description
Picosecond Nd:YAG Laser Systems, pulse width: <500ps; pulse energy up to 500mJ, instantaneous emission of laser energy efficient crushing lesions tissue chromophore, that is photon burst: laser accumulation energy is instantaneous emission. The instrument uses the laser-wave to break Chromatophore into pieces which can be naturally absorbed by the body. So that it achieves the purpose of de-freckling. The 1064 nm wavelength will shatter and removes the black, blue, purple and brown pigments while the 532 nm wavelength will shatter and removes red, pink, yellow and orange pigments of the tattoo or other pigmentations without damaging the normal tissue. Apply for tattoo and tattoo epidermal/ dermal lesion pigmented, lesions removal. Picosecond laser is being introduced as the first safe and effective aesthetic laser specifically designed to treat tattoos and pigmented lesions. This innovative laser delivers ultra short pulse bursts of energy to the skin in trillionths of a second. These pulses create a photomechanical effect, that target ink while avoiding unmarked tissue. The pulse shatters the ink into tiny, dust-like particles which are easily eliminated by the body.
Summary parsed at:2026-06-01 05:27:17 UTC
Predicate devices
2PicoSecond Nd: YAG Laser System
Diode Laser System
K240118 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K240118 as a predicate
