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510(k) Data Aggregation
K Number
K152452Device Name
Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
Manufacturer
Date Cleared
2016-05-19
(265 days)
Regulation Number
878.4635Why did this record match?
Applicant Name (Manufacturer) :
MEDTEK LIGHTING CORP D/B/A PEACOCK TANNING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Medtek Lighting, LLC's Peacock Tanning, Express Tan Models 1000HT, 2000CT, 2000HT, 3200 are intended to provide ultraviolet light to tan the skin, in male and female users, not under the age of 18 years.
Device Description
The Express Tan 1000HT device is a skin tanning device, wall mounted or used on an accessory stand with a single lighting panel with 10 Cosmedico (T12/F71"/100w) lamps, driven by standard electrical lighting systems at 120 Volts, producing primary UV-A emissions within an enclosed metal (structure) and acrylic (exposure) housing and utilized only with included protective eyewear, as outlined in 21 CFR 1040.20 (c). A digital timer is used to program exposure times. Cabinet dimensions: 85.5" high, 5" deep, 22" wide - when door panels are closed. A digital control timer module is used to program exposure times.
The Express Tan models1600HT/2000CT/2000HT/3200 are skin tanning devices, wall mounted with 4 lighting panels containing an array of a total of 16, 20, or 32 Cosmedico (T12/F71"/100w) lamps, driven by standard electrical lighting systems at 120 Volts, producing UV-A emissions within an enclosed metal (structure) and acrylic (exposure) housing, and that is utilized only with included protective eyewear, as outlined in 21 CFR 1040.20 (c). A digital timer is used to program exposure times. Cabinet dimensions: 92" high, 8" deep, 50" wide - when panels are closed.
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K Number
K134009Device Name
UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL
Manufacturer
Date Cleared
2014-10-15
(289 days)
Product Code
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
MEDTEK LIGHTING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The UV Biotek Multi-Directional device is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).
The UV Biotek Single Panel Unit device models 100B/80B/40B are for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)
Device Description
The UV Biotek Multi-Directional model is a phototherapy device, wall mounted with 3 lighting panels containing a total of 10 Philips TL100W/01 (narrowband UVB) or 10 Philips FS72T12/BL/HO/12 (wideband UVB) lamps. The center panel contains 6 lamps and the outer panels contain 2 lamps each, driven by standard electrical lighting systems at 120 Volts, producing 1000 Watts of primary UVB emissions within an enclosed metal (structure) and acrylic (exposure) housing, that is utilized at a the patient's home by prescription, and only with protective eyewear, as outlined in 21 CFR 892.6500. Cabinet dimensions: 85.5" high, 9" deep, 22.5" wide – when the door panels are closed. A digital AccuSafe control timer module is used to program exposure times and dosages.
The UV Biotek Single Panel device is a phototherapy device, wall mounted with a single lighting panel with an array of 4, 6, 8 or 10 Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps, driven by standard electrical lighting systems at 120 Volts, producing 400 to 1000 Watts of primary UVB emissions within an enclosed metal (structure) and acrylic (exposure) housing, that is utilized at a the patient's home by prescription, and only with protective eyewear, as outlined in 21 CFR 892.6500.
Cabinet dimensions: 85.5" high, 5" deep, 22" wide – when door panels are closed. A digital AccuSafe control timer module is used to program exposure times and dosages.
There are 4 single panel models to choose from:
. The100B model is one metal cabinet, housing (10) Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
The 80B model is one metal cabinet, housing (8) Philips TL100W/01 ● (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
. The 60B model is one metal cabinet, housing (6) Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
. The 40B model is one metal cabinet, housing (4) Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
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K Number
K111049Device Name
MOBILE VERSA LIGHT
Manufacturer
Date Cleared
2012-05-25
(406 days)
Product Code
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
MEDTEK LIGHTING CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The UV Biotek Mobile-Lite model 600 is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)
The UV Biotek Versa-Lite model 1400 is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)
Device Description
The UV Biotek Mobile-Lite model 600 is a lightweight metal box containing six Philips 15-Watt TL-01 nUVB (narrowband UVB) lamps, configured as a suitcase for portability, designed to be placed either on a table or a stand for easy exposure to feet, lower legs, hands and lower arms. A remote control timer module is used to program exposure times and dosages.
The UV Biotek Versa-Lite model 1400 is a phototherapy device, freestanding support with 3 lighting panels containing a total of 14 Philips TL20W/01 (narrowband UVB) lamps. The panels can be used simultaneously or individually, depending on treatment needed. System dimensions: 83" high, 27" deep, and 28" wide - when system panels are in start position.
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K Number
K051330Device Name
UVBIOTEK MODELS 3200B AND 4000B
Manufacturer
Date Cleared
2005-11-18
(182 days)
Product Code
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
MEDTEK LIGHTING CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sec. 878.4630, Ultraviolet lamp for dermatologic disorders - to provide ultraviolet (UVB) radiation of the body to photoactivate a drug in the treatment of dermatologic disorders.
Device Description
Not Found
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