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Found 5 results
510(k) Data Aggregation
K Number
K090820Device Name
TRIA HAIR REMOVAL LASER SYSTEM
Manufacturer
SPECTRAGENICS, INC.
Date Cleared
2009-12-23
(272 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SPECTRAGENICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TRIA is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. TRIA is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
Device Description
TRIA is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.
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K Number
K053527Device Name
SPECTRA HAIR REMOVAL LASER
Manufacturer
SPECTRAGENICS, INC.
Date Cleared
2008-02-01
(774 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SPECTRAGENICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectra Hair Removal Laser System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.
Device Description
The Spectra Hair Removal System consists of the Spectra Laser and Spectra Skin Sensor. The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm. The Spectra Skin Sensor determines whether users can safely use the Spectra Hair Removal Laser.
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K Number
K060567Device Name
SPECTRAGENICS ATS-1
Manufacturer
SPECTRAGENICS, INC.
Date Cleared
2006-04-28
(56 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SPECTRAGENICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SpectraGenics ATS-1 is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
Device Description
The SpectraGenics ATS-1 is a handheld, electrically-powered light therapy device that produces light at a wavelength of nominally 410 nm.
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K Number
K052848Device Name
SPECTRA HAIR REMOVAL LASER
Manufacturer
SPECTRAGENICS, INC.
Date Cleared
2005-12-27
(81 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SPECTRAGENICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectra Hair Removal Laser is intended for temporary hair removal.
Device Description
The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.
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K Number
K032846Device Name
SPECTRA PULSED DIODE LASER, MODEL DR-1
Manufacturer
SPECTRAGENICS, INC.
Date Cleared
2003-12-11
(91 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SPECTRAGENICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectra Hair Removal Laser is intended to effect temporary hair removal.
Device Description
The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.
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