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510(k) Data Aggregation
K Number
K202257Device Name
Dermatological Diode Laser Systems
Date Cleared
2021-04-23
(256 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Zhuolu Jontelaser Manufacturing Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dermatological Diode Laser Systems is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent 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 proposed device, Diode Laser Therapy System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
There are 2 models included, T5 Pro and T8 Pro, the two models have same intended use, mechanism of action, principle and specification, only difference is the configuration.
The main components of proposed device shown as following: Handpiece, Touchscreen, Emergency Switch, Key Switch, Connector, Indicator Lamp, Foot Switch.
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K Number
K202250Device Name
Dermatological Carbon Dioxide Laser Systems
Date Cleared
2020-11-25
(107 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Zhuolu Jontelaser Manufacturing Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dermatological Carbon Dioxide Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Device Description
The Dermatological Carbon Dioxide Laser Systems, and it is also a gas laser. With its own wavelength of 10600 nm, the laser energy density is high and the divergence angle is very small. The focus light beam was used to vaporization, coagulation the human tissue.
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