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510(k) Data Aggregation
K Number
K031680Device Name
SPECTRAPULSE
Manufacturer
Date Cleared
2003-06-24
(25 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PRIMARY TECHNOLOGY, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Spectrapulse® pulsed light system is intended for photothermolysis of blood vessels (facial and leg veins), photocoagulation of dermatological vascular lesions, and the treatment of benign pigmented lesions for skin types I - IV according to the Fitzpatrick scale.
The Spectrapulse® pulsed light system is intended for long term hair removal on skin types I-V according to the Fitzpatrick scale.
Device Description
The SpectraPulse system is a light-based medical device designed for long term hair removal on skin types I-V
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K Number
K022607Device Name
SPECTRAPULSE
Manufacturer
Date Cleared
2002-12-20
(136 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PRIMARY TECHNOLOGY, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SpectraPulse system is indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (facial and leg veins), benign pigmented lesions in skin types I-IV according to the Fitzpatrick scale.
The Spectrapulse® pulsed light system is intended for photothermolysis of blood vessels (facial and leg veins), photocoagulation of dermatological vascular lesions, and the treatment of benign pigmented lesions for skin types I - IV according to the Fitzpatrick scale.
Device Description
The SpectraPulse system is a light-based medical device designed for treatment of vascular lesions (fascial and leg) and benign pigmented lesions.
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