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510(k) Data Aggregation
K Number
K043319Device Name
CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES
Manufacturer
NOVALIS MEDICAL, LLC
Date Cleared
2004-12-17
(15 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
NOVALIS MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Clareon™ and Solarus™ Pulsed Light Systems are light-based medical device(s) intended for use with the following:
HR Handpiece - Permanent hair reduction.
AR Handpiece - Treatment of inflammatory acne.
VR Handpiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions.
SR Handpiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions. Removal of unwanted hair.
Device Description
The Clareon™ and Solarus™ Pulsed Light Systems are light-based medical device(s) which incorporate the use of the following accessory handpieces that are designed for specific treatments / uses: HR Handpiece - Permanent Hair reduction on all skin types; SR Handpiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions and removal of unwanted hair; VR Handpiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions; AR Handpiece - Treatment of inflammatory Acne on skin types I-IV.
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