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510(k) Data Aggregation
K Number
K123889Device Name
ACLEARA, THERACLEAR
Manufacturer
Date Cleared
2013-03-04
(76 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
THERAVANT CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Theravant Acleara/TheraClear System is intended for the treatment of benign vascular and pigmented lesions; permanent hair reduction; and the treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris), in all skin types (Fitzpatrick I-VI).
Device Description
The Theravant System is comprised of the following main components: Main console, Treatment Handpiece(s). The Theravant System is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing vacuum technology. Intense pulsed light is emitted through the tip only when the tip is sealed against the selected patient treatment site. All emitted light is contained within the tip during treatment. A modification to the handpiece includes a needle accessory for use during the treatment of inflammatory acne lesions. The modified handpiece does not introduce any changes to the principles of operation as compared to the traditional handpiece. The modified handpiece uses vacuum to confine and stretch the target region, coupled with a fine gauge needle to facilitate the release of sebum from the pilosebaceous unit.
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K Number
K101415Device Name
THERACLEAR
Manufacturer
Date Cleared
2010-07-08
(49 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
THERAVANT CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Theravant TheraClear System is intended for the treatment of benign vascular and pigmented lesions; permanent hair reduction; and the treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris), in all skin types (Fitzpatrick types I-VI).
Device Description
The Theravant System is comprised of the following main components: Main console, Treatment Handpiece(s). The Theravant System is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing vacuum technology. Intense pulsed light is emitted through the tip only when the tip is sealed against the selected patient treatment site. All emitted light is contained within the tip during treatment.
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Ask a specific question about this device
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