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510(k) Data Aggregation
K Number
K180585Device Name
Collagentex Rx-6
Manufacturer
Date Cleared
2018-05-11
(67 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Tanses Technologies inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Collagentex RX-6 model is intended to emit light energy in the near infrared spectrum to provide non heating adjunctive use for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Device Description
The Collagentex Rx-6 is a stand alone light device which emits polychromatic visible to near infrared light in the 580 to 1500 nanometer range. The light is non-collimating and non-pulsing. There are a total of 6 exposure areas, each set to receive 44.2miliWatt/sqcm or 2.6 Joule/minute at the minimum distance of 8 inches.
The device measures 96 inches long by 27.68 inches wide by 96 inches tall and is made up of 3 main sections. There are 2 vertical towers positioned 84 inches apart. The towers are made of metal and house the main electrical components for the device. A control console which includes a set timer, emergency stop button, oscillating on/off switch and a mechanical hour counter is mounted on left positioned tower.
In between the towers, positioned horizontally is a lamp module. The lamp module is made up of 6 individual lamp assemblies placed inline. The lamps are all 500w quartz type and each cover an exposure area of 23cm diameter. The height of the lamp module is adjustable via actuators positioned in the vertical columns. The actuators are controlled by a wired remote control. The device is to be mounted on the floor above a massage table provided by the device owner.
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K Number
K162022Device Name
Collagentex Rx-1
Manufacturer
Date Cleared
2016-12-22
(154 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Tanses Technologies inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Collagentex RX-1 model is intended to emit light energy in the near infrared spectrum to provide non heating adjunctive use for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Device Description
Collagentex RX-1 model is a stand alone device of a single quartz lamp, emitting polychromatic visible to near infrared light from 580nm to 1500nm, non-collimating, non pulsing in order to offer exposure to the user where directed at a distance of 8" and farther from the body, non topical light therapy in order to relieve minor pain temporarily. The unit can be mounted on a table top or rolled on a base with casters. Narrow band filter and acrylic shield are designed to eliminate any emission of ultraviolet or wavelength shorter than 480nm wavelengths. The lamp replacement life is 500hrs. The exposure dosage is controlled by a user set timer. Exposure area is set to receive 44.2miliWatt/sqcm or 2.6 Joule/minute of exposure at the minimum distance. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power.
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K Number
K152412Device Name
T-32;T-40;T-44;T-52;T-72;TT-50
Manufacturer
Date Cleared
2016-04-29
(247 days)
Product Code
Regulation Number
878.4635Why did this record match?
Applicant Name (Manufacturer) :
Tanses Technologies inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the T-Series tanning beds and booth is solely for the tanning of the human skin.
Device Description
The T-Series tanning beds and booth are devices that omit ultraviolet radiation in the UVA and UVB range to produce a cosmetic tan. The T-Series family of units is made up of five (5) lay-down beds and one (1) stand-up unit. All the lay-down beds in the T-Series are similar in design. They are made up of 3 sections, a canopy or top section (tans the front side of the user), a base or bed section (tans the back side of the user) and a side console (made up of cooling fans and controls). The beds are all 87" long and vary in width from 35 inches to 59 inches. The main difference in the bed design between the five (5) models is the amount of ultraviolet sunlamps they are equipped with. The T-32 is equipped with 32 ultraviolet sunlamps. The T-40 is equipped with 40 ultraviolet sunlamps. The T-44 is equipped with 44 ultraviolet sunlamps. The T-52 is equipped with 52 ultraviolet sunlamps. The T-72 is equipped with 64 ultraviolet sunlamps. The laydown beds are also designed to be equipped with optional face bulbs. The face bulbs are installed in the canopy section. Each unit can be outfitted with up to 3 face bulbs. The lay-down beds are constructed of the same materials. Their frames are made up of power coated steel, stainless steel and anodized aluminum. All the beds are equipped with an acrylic sheet in both the base and canopy sections. The acrylic sheet is designed specifically for the transmission of ultraviolet light in the UVA and UVB range. The acrylic sheets also server as a barrier to protect the user from lamp breakage and for sanitary purposes. The lay-down beds also share the exact same electrical components which mainly consist of a choke type ballast, starter and fluorescent sunlamp. The choke ballast acts like a valve and limits the amount of power/wattage to the lamp. The starter is needed in the initial start-up of the lamp; it generates an inductive kick which provides the high voltage needed to start the lamp. The fluorescent sunlamp is made specifically for tanning equipment. It is a low pressure mercury vapor gas-discharge lamp that emits most of its energy in the UVA and UVB range between 260nm-400nm. The ballast, starter and fluorescent sunlamp used in our lay-down beds are available in 100 Watt, 160 Watt or 200 Watt confiquration. The face bulbs are physically smaller than the fluorescent sunlamps and are made of a quartz glass. They also work with a ballast and starter system. The ballast, starter/ignitor and face bulb are 400 watts. The T-series booth (TT-50) is designed for a vertical application. It has the same metal construction as in the lay-down beds and also outfitted with the same electrical components. The booth is made up of 7 sections. One (1) floor platform which is made of stainless steel. Five (5) vertical columns, each equipped with ten (10) fluorescent sunlamps One (1) overhead section which consists of an 18 inch cooling fan and controls. Each sunlamp column is equipped with a powder coated steel grid to prevent the user from contacting the lamps. There handles attached to the overhead section in which the user can hold on to while tanning. The handles are made of steel and chromes plated. Face tanners are not available for the stand-up booth. Both our lay-down beds and stand-up unit are configured to work with a timer system to ensure than the users of the equipment do not overexpose themselves to the ultraviolet light. The T-Series tanning beds and booth require 220 volts AC.
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