(247 days)
There are no predicate devices with a K/DEN number listed in the provided text. The text states: "The T-Series tanning beds and booth listed in this 510(k) were all existing models, available for purchase in the US as legally marketed, class I, medical devices, 510k exempt, prior to September 2, 2014 and has been in the market since 1992 without any harm to any user."
Not Found
No
The device description focuses on the physical components and electrical systems of a tanning bed, with no mention of AI or ML technologies. The performance studies listed are related to electrical safety and photobiological safety, not AI/ML performance metrics.
No.
The intended use of the device is solely for the tanning of human skin, which is a cosmetic purpose, not a therapeutic one.
No
The document explicitly states that "The intended use of the T-Series tanning beds and booth is solely for the tanning of the human skin." It describes the device as emitting ultraviolet radiation for cosmetic tanning, not for diagnosis.
No
The device description clearly outlines physical hardware components such as beds, booths, lamps, ballasts, starters, frames, acrylic sheets, and electrical components. There is no mention of software being the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "solely for the tanning of the human skin." This is a cosmetic purpose, not a diagnostic one.
- Device Description: The device emits ultraviolet radiation to produce a cosmetic tan. It does not perform any tests on biological samples (in vitro).
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing blood, urine, tissue, or other biological specimens.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This tanning bed does not fit that definition.
N/A
Intended Use / Indications for Use
The intended use of the T-Series tanning beds and booth is solely for the tanning of the human skin.
Product codes
LEJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tanses tanning equipment models have been tested and found satisfactory to the following tests and standards.
- IEC 60601-1-2 3rd edition medical electrical equipment Elecromagnetic compatibility/EMI requirements
- CSA/NRTL Class 3872-85, 3872-05 electrical standards, ANSI-UL1431, UL 482, CAN/CSA-C22.2 No224 M89
- Photo biological Safety evaluation of Optical emissions by Optronics Labs and RPTL labs for spectral analysis and time schedules
- . Timer testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The T-Series tanning beds and booth listed in this 510(k) were all existing models, available for purchase in the US as legally marketed, class I, medical devices, 510k exempt, prior to September 2, 2014 and has been in the market since 1992 without any harm to any user.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
(a)
Identification. A sunlamp product is any device designed to incorporate one or more ultraviolet (UV) lamps intended for irradiation of any part of the living human body, by UV radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning. This definition includes tanning beds and tanning booths. A UV lamp intended for use in sunlamp products is any lamp that produces UV radiation in the wavelength interval of 200 to 400 nanometers in air.(b)
Classification. Class II (special controls). The special controls for sunlamp products and UV lamps intended for use in sunlamp products are:(1) Conduct performance testing that demonstrates the following:
(i) Device meets appropriate output performance specifications such as wavelengths, energy density, and lamp life; and
(ii) Device's safety features, such as timers to limit UV exposure and alarms, function properly.
(2) Demonstrate that device is mechanically safe to prevent user injury.
(3) Demonstrate software verification, validation, and hazard analysis.
(4) Demonstrate that device is biocompatible.
(5) Demonstrate that device is electrically safe and electromagnetically compatible in its intended use environment.
(6)
Labeling —(i)Sunlamp products. (A) The warning statement below must appear on all sunlamp products and must be placed in a black box. This statement must be permanently affixed or inscribed on the product when fully assembled for use so as to be legible and readily accessible to view by the person who will be exposed to UV radiation immediately before the use of the product. It shall be of sufficient durability to remain legible throughout the expected lifetime of the product. It shall appear on a part or panel displayed prominently under normal conditions of use so that it is readily accessible to view whether the tanning bed canopy (or tanning booth door) is open or closed when the person who will be exposed approaches the equipment and the text shall be at least 10 millimeters (height). Labeling on the device must include the following statement: Attention: This sunlamp product should not be used on persons under the age of 18 years. (B) Manufacturers shall provide validated instructions on cleaning and disinfection of sunlamp products between uses in the user instructions.
(ii)
Sunlamp products and UV lamps intended for use in sunlamp products. Manufacturers of sunlamp products and UV lamps intended for use in sunlamp products shall provide or cause to be provided in the user instructions, as well as all consumer-directed catalogs, specification sheets, descriptive brochures, and Web pages in which sunlamp products or UV lamps intended for use in sunlamp products are offered for sale, the following contraindication and warning statements:(A) “Contraindication: This product is contraindicated for use on persons under the age of 18 years.”
(B) “Contraindication: This product must not be used if skin lesions or open wounds are present.”
(C) “Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer.”
(D) “Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
(c)
Performance standard. Sunlamp products and UV lamps intended for use in sunlamp products are subject to the electronic product performance standard at § 1040.20 of this chapter.
0
Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human profiles facing right. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2016
Tanses Technologies Inc. Mr. Kirk Kiremitci President 4450 Highway 13 Fabreville, H7R 6E9 CA
Re: K152412
Trade/Device Name: T-32;T-40;T-44;T-52;T-72;TT-50 Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet Lamp For Tanning Regulatory Class: Class II Product Code: LEJ Dated: August 17, 2015 Received: August 26, 2015
Dear Mr. Kirk Kiremitci:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
T-Series Tanning beds and booths
Indications for Use (Describe)
The intended use of the T-Series tanning beds and booth is solely for the tanning of the human skin.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Date Prepared: | August 28, 2015 |
|---|---|
| Company name: | Tanses Technologies inc. |
| Address: | 4450 Highway 13 |
| Laval, Quebec | |
| H7R 6E9 | |
| Canada | |
| Telephone number: | 450-622-4004 |
| Fax number: | 450-622-1540 |
| Contact name: | Kirk Kiremitci |
| e-mail: | kirk@tanses.com |
| Device trade name: | Tanses Tanning beds and booth |
| Device model names: | T32, T40, T44, T52,T72, TT50 |
| Common/Usual name: | Tanning bed and booth |
| Classification name: | Sunlamp product |
| Classification code: | LEJ |
| Device Classification: | II |
| Requlation number: | 21 CFR Part 878.4635 |
4
Predicate device
The T-Series tanning beds and booth listed in this 510(k) were all existing models, available for purchase in the US as legally marketed, class I, medical devices, 510k exempt, prior to September 2, 2014 and has been in the market since 1992 without any harm to any user.
As stated in the Final Reclassification Order published on June 2, 2014 in the Federal Register Vol. 79, No. 105, Page 31212 " Any 510(k)-exempt sunlamp product or UV lamp intended for use in a sunlamp product legally offered for sale on or before September 2, 2014, can serve as a predicate for substantial equivalence purposes." We Tanses Technologies inc. would like to claim substantial equivalence to these legally marketed devices for this 510(k).
There have been no changes in either intended use or technological characteristics between the predicate devices and the devices named in this 510(k) since the September 2, 2014 cut-off date. As a result, the devices named in this 510(k) are as safe, as effective, and performs as well as the predicate devices.
Intended Use
The intended use for the T-Series tanning beds and booth is solely for the tanning of the human skin.
Description of the Devices
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
5
UVB range. The acrylic sheets also server as a barrier to protect the user from lamp breakage and for sanitary purposes.
Page 5.2
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.
Technological Characteristics
The Technological characteristics of the tanning beds and booth is this 510(k) are the exact same as those in the predicate devices.
Performance Testing, Data
Tanses tanning equipment models have been tested and found satisfactory to the following tests and standards.
- IEC 60601-1-2 3rd edition medical electrical equipment Elecromagnetic compatibility/EMI requirements
- CSA/NRTL Class 3872-85, 3872-05 electrical standards, ANSI-UL1431, UL 482, CAN/CSA-C22.2 No224 M89
- Photo biological Safety evaluation of Optical emissions by Optronics Labs and RPTL labs for spectral analysis and time schedules
- . Timer testing
CONCLUSION
Tanses tanning equipment is substantially equivalent to its Class-I predicate models without changes.