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510(k) Data Aggregation
K Number
K182604Device Name
New Era
Manufacturer
Date Cleared
2018-11-14
(54 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Step Up Skin Laser, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The New Era Laser is intended for 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, New Era, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
There is one model, FG 2000.
The main components of proposed device shown as following: Handpiece, Emergency Switch, Key Switch, Connector, Indicator Lamp, Foot Switch.
The proposed system provides 36 working modes, which are six modes for men and six modes for women, the men or women mode includes Parameter one, two, three, four, five and six mode respectively for different preset parameter combination, and each particular parameter preset mode includes three submode as mode 1, mode 2 and mode 3.
The difference for each mode is only the default parameter, but all parameters for each mode can be adjustable in the parameter range.
The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black);
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