Manufacturer
Rhein Laser Technologies Co., Ltd.Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)
Rhein Laser Technologies 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
- K233756
- Device name
- Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-11-24
- Decision date
- 2024-02-02
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The indications for use for the RL-S20S-TWC include: The Super Hair Removal (SHR) Mode are intended for temporary hair reduction. The indications for use for the RL-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. The indications for use for the RL-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.
Intended Use
The indications for use for the RL-S20S-TWC include: The Super Hair Removal (SHR) Mode are intended for temporary hair reduction. The indications for use for the RL-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. The indications for use for the RL-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.
Summary parsed at:2026-06-01 05:27:00 UTC
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