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510(k) Data Aggregation
K Number
K061295Device Name
VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
Manufacturer
THERALIGHT, INC.
Date Cleared
2006-05-25
(16 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
THERALIGHT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VersaClear™ Skin Therapy System UVA (350mm) Light Module is indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.
Device Description
The VersaClear™ Skin Therapy System UVA (350mm) Light Module is a 120/240V 50/60 Hz AC illumination source that emits UVA radiation with a peak at 350mm ± S mm.
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K Number
K051259Device Name
VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
Manufacturer
THERALIGHT, INC.
Date Cleared
2005-09-20
(127 days)
Product Code
GEX, FTC
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
THERALIGHT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VersaClear Skin Therapy System is generally indicated to treat dermatological conditions. Blue light modules are indicated to treat moderate inflammatory acne vulgaris. Red light modules are indicated for use in combination with blue light for the treatment of moderate inflammatory acne vulgaris, and for use alone in the treatment of superficial, benign vascular, and pigmented lesions. UVA light modules are indicated for individuals who require specific ultraviolet radiation therapy for diagnosed skin disorders.
Device Description
The VersaClear™ Skin Therapy System is a 120/240V 50/60 Hz AC illumination source consisting of one or more light modules. A set of light modules emits a specific narrow spectrum of light, namely blue (420 ± 2nm), red (615 ± 3nm), or UVA (368 ± 3nm). The light modules are mounted on a positioning arm attached to a mobile or stationary pedestal, a wall, or a countertop. This flexible design accommodates varying office spatial settings, and allows for the treatment of patients who are sitting, reclining, or lying down. Light modules are interchangeable to maximize System versatility.
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K Number
K024020Device Name
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM
Manufacturer
THERALIGHT, INC.
Date Cleared
2003-01-17
(43 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
THERALIGHT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TheraLight UV120-2 UVA / UVB Phototherapy System is indicated for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the System UVB channel is indicated for the treatment of leukoderma.
Device Description
The TheraLight UV120-2 UVA / UVB Phototherapy System is a microprocessorcontrolled, high-intensity ultraviolet light source. The desired dose of UVA or UVB light is selected using controls on the System front panel. The System provides "targeted" phototherapy, whereby the specified dose of UVA or UVB light is delivered via a flexible Lightguide and Handpiece. The System delivers a homogenous UV light dose to a localized ¾" square patch of skin without exposure to neighboring, healthy tissues.
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K Number
K022165Device Name
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2
Manufacturer
THERALIGHT, INC.
Date Cleared
2002-07-18
(15 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
THERALIGHT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TheraLight UV120-2 UVA / UVB Phototherapy System is indicated for use in PUVA photochemistry and UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis.
Device Description
The TheraLight UV120-2 UVA / UVB Phototherapy System is a microprocessorcontrolled, high-intensity ultraviolet light source. The desired dose of UVA or UVB light is selected using controls on the System front panel. The System provides "targeted" phototherapy, whereby the specified dose of UVA or UVB light is delivered via a flexible Lightguide and Handpiece. The System delivers a homogenous UV light dose to a localized ¼'' square patch of skin without exposure to neighboring, healthy tissues.
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