Search Results
Found 1 results
510(k) Data Aggregation
K Number
K210663Device Name
Dermatological Diode Laser Systems
Manufacturer
Beijing HuaCheng Taike Technology Co., Ltd.
Date Cleared
2021-04-26
(52 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Beijing HuaCheng Taike Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dermatological Diode Laser Systems(Model: CM01D/CM02D) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-V), including tanned hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Device Description
The Dermatological Diode Laser Systems utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via s laser handpiece. The emission laser is activated by a foot-switch. There are 2 models included,CM01D,CM02D, the two models have same mechanism of action, principle and specification, only difference is the configuration.
Ask a Question
Page 1 of 1