Manufacturer
Theralaser Medtech (China) Co., Ltd.Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)
Theralaser Medtech (China) 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
- K240874
- Device name
- Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-03-29
- Decision date
- 2024-05-28
- 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 TL-S20S-TWC include: The Super Hair Removal (SHR) Mode are intended for temporary hair reduction. The indications for use for the TL-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 TL-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).
Intended Use
The indications for use for the TL-S20S-TWC include: The Super Hair Removal (SHR) Mode are intended for temporary hair reduction. The indications for use for the TL-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 TL-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).
Summary parsed at:2026-06-01 05:28:06 UTC
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