SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC

Lotuxs Medtech (Suzhou) Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

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1

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K222862
Device name
SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-09-22
Decision date
2023-07-30
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin. The indications for use for NIR Modules are: Elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness. The temporary relief of minor joint pain associated with arthritis. The temporary increase in local circulation where applied, and the relaxation of muscles may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Intended Use

The indications for use for the SILKPRO-S20S-TWC include: The Super Hair Removal (SHR) Mode are intended for temporary hair reduction. The indications for use for the SILKPRO-S20S-755A include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin. (HR, SHR Modes) The indications for use for the SILKPRO-S20S-810B include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin. (HR, and SHR Modes)

Device Description

The working principle of SILKPRO Titanium Diode Laser System is selective photothermal effect. It uses its unique long pulse width laser to penetrate the epidermis to the hair follicle. The energy of the laser is preferentially absorbed by the melanin in the hair, so that the hair follicle produces high heat. Thereby destroying the structure of the hair follicle, making the hair lose the ability to regenerate, and achieving the purpose of hair removal. The treatment head adopts a uniquely designed sapphire dynamic cooling device. SILKPRO Titanium Diode Laser System is a sophisticated high-tech laser equipment. The machine includes water cooling system. Water flows through the pipes in the handpiece to dissipate heat for the light source and the TEC water cooling block, which is used to cool the skin tissue during treatment.

Summary parsed at:2026-06-01 05:32:01 UTC

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