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510(k) Data Aggregation
K Number
K133546Device Name
STARLITE-OM, LIGHT EFFECTS, THIBIANT
Manufacturer
Date Cleared
2014-08-06
(260 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PS ADVANCED ENGINEERING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SL-8813 is an Over The Counter (OTC) handheld device intended for in the treatment of full face wrinkles
Device Description
SL-8813 is a handheld ergonomically designed ABS plastic housed device with a locking Medical Grade Stainless Steel retainer holding in place a Medical Grade USP Class polycarbonate lens from which high spectral purity LED light in 4 (four) specific wavelengths is emitted. By design the optical output has a high degree of homogenous light distribution. The output wavelengths are actuated via a simple on-off swipe button and are in the visible Red and the Infrared spectrum. SL8813 is powered by a built in (non user accessible) Lithium lon Battery which can be charged as required via a supplied UL listed AC/DC wall mounted unit. Treatment time for light outputs is controlled by the operator as per Treatment Protocols listed in User Documentation. Audible announcement is provided to the user for timing intervals of treatments and is so noted in User Documentation.
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K Number
K092460Device Name
STAR-LITE -LM, MODEL SL8809
Manufacturer
Date Cleared
2010-03-05
(206 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PS ADVANCED ENGINEERING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The StarLite-LM is a hand held device intended for Over The Counter patient usage to specifically reduce periorbital wrinkles. The target patient population would be identical to the population of the predicate device. StarLite-LM emits LED light energy in the Red and Infrared region.
Device Description
StarLite-LM is a handheld ergonomically designed ABS plastic housed device with a locking Medical Grade Stainless Steel retainer holding in place a Medical Grade polycarbonate lens from which high spectral purity LED light in 2 (two) specific wavelengths is emitted. By design the optical output has a high degree of homogenous light distribution. The output wavelengths are user selected via a simple pushbutton on alternate treatment days and are in the visible Red and the Infrared spectrum. StarLite-LM is powered by a built in Lithium lon Battery which can be charged as required via a supplied UL listed AC/DC wall mounted unit. Treatment time for both light outputs is controlled by the operator as per Treatment Protocols listed in User Documentation.
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