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510(k) Data Aggregation
K Number
K112141Device Name
SMARTEPIL,DEPILASE YAG LASE PLUS
Manufacturer
Date Cleared
2012-04-13
(262 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CASTLE LASER SYSTEMS, LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CLS001 Laser System is intended to effect stable, long-term or permanent hair reduction, in Fitzpatrick skin types I-VI, including sun tanned skin types. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing after a treatment regime
The CLS001 Laser System is intended to effect coagulation and haemostatis of vascular lesions in Fitzpatrick skin types I-VI, including suntanned skin types.
Device Description
The CLS001 Laser System is an analog, pulsed Nd: YAG laser utilizing the Nd: YAG crystal as the lasing medium. It operates at the wavelength of 1064 nanometers. Laser activation is controlled by a footswitch mechanism. Physically, the system weighs 66 pounds, is 13.8 inches high, 23.6 inches wide and 17.3 inches deep. The electrical requirements are 220/240 VAC single phase, 50/60 Hz and 8 amps.
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