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Found 5 results
510(k) Data Aggregation
K Number
K160821Device Name
Tria Sapphire
Manufacturer
TRIA BEAUTY, INC.
Date Cleared
2016-06-15
(83 days)
Product Code
OLP
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TRIA BEAUTY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tria Sapphire is indicated for the treatment of mild to moderate inflammatory acne. It is intended for over-the-counter use.
Device Description
The Tria Sapphire is a handheld, electrically powered device that uses LEDs (light emitting diodes) to produce therapeutic blue light.
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K Number
K141868Device Name
TRIA FANP
Manufacturer
TRIA BEAUTY, INC.
Date Cleared
2014-12-30
(173 days)
Product Code
ONG
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TRIA BEAUTY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tria FANp is an over-the-counter device indicated for the treatment of periorbital wrinkles (crow's feet).
Device Description
The Tria FANp is a semiconductor diode laser system that delivers infrared light at a wavelength of 1450 nm ± 50 nm.
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K Number
K130459Device Name
TRIA FAN SYSTEM
Manufacturer
TRIA BEAUTY, INC.
Date Cleared
2013-10-25
(245 days)
Product Code
ONG
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TRIA BEAUTY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tria FAN is indicated for the treatment of periorbital wrinkles, which may result in smoother appearing skin in the treated area.
Device Description
The Tria FAN System is a semiconductor diode laser system that delivers infrared light at a wavelength of 1450 nm ± 50 nm.
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K Number
K120737Device Name
TRIA LASER HAIR REMOVAL SYSTEM
Manufacturer
TRIA BEAUTY, INC.
Date Cleared
2012-09-13
(188 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TRIA BEAUTY, 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. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
Device Description
TRIA is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm +/- 20%.
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K Number
K090312Device Name
TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC
Manufacturer
TRIA BEAUTY, INC.
Date Cleared
2010-01-05
(333 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TRIA BEAUTY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ATS-1 OTC is generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris. It is intended for over-the-counter use.
Device Description
The ATS-1 OTC is a handheld, electrically powered device that uses LEDs (light emitting diodes) to produce therapeutic blue light.
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