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510(k) Data Aggregation
K Number
K240874Device Name
Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)
Manufacturer
Date Cleared
2024-05-28
(60 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TheraLaser Medtech (China) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 L-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 airs 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
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