(237 days)
uwe sun tanning beds/booths
Not Found
No
The description focuses on the physical components and UV radiation properties of a tanning bed, with no mention of AI or ML technologies.
No
Therapeutic devices are intended to treat or alleviate a medical condition. This device is intended for tanning the skin, which is a cosmetic purpose, not a medical treatment.
No
Diagnostic devices are used to identify or detect a disease or condition. This device is intended to tan the skin, which is a cosmetic purpose, not a diagnostic one.
No
The device description explicitly details hardware components such as a lying area, canopy, cabin, door, electronic components (main board, relay board, fans, lamps), filters, reflectors, and a mechanical structure. The performance studies also mention testing of electrical, thermal, mechanical, and environmental aspects, further indicating a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide ultraviolet light to tan the skin." This is a direct interaction with the human body for a cosmetic purpose (tanning).
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a device that emits UV radiation to affect the skin directly. It does not mention any analysis of biological samples.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples
- Diagnostic claims
- Performance metrics like sensitivity, specificity, etc. (which are relevant to diagnostic tests)
Therefore, the uwe sun tanning beds/booths, as described, fall under the category of devices that interact directly with the body for a non-diagnostic purpose, making them not IVDs.
N/A
Intended Use / Indications for Use
Intended to provide ultraviolet light to tan the skin.
Product codes (comma separated list FDA assigned to the subject device)
LEJ
Device Description
The uwe sun tanning beds/booths consist of several essential parts. These parts differ between the bed and the booth models.
The beds consist of a lying area and a canopy. The booth consists of a cabin and a door. Both sunlamp products contain the same electronic components like the main board and the relay board, fans, lamps etc.
The most significant differences are the decorating design elements and the implemented features like "Body Mist" and "Aroma". These constitute the several looks of the beds and booths.
The primary technical components of a tanning device are an artificial source of UV radiation, a variety of filters and reflectors as well as a mechanical structure with a defined active surface. Different tanning results can be achieved in varying strength tanning devices. This is due to the different strength UV lamps and the different UV-A and UV-B proportions of the UV radiation.
The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly, the UV-B radiation is primarily responsible for more long-term tanning results.
The disadvantage of the UV-B radiation is that the tan does not become visible until one or two days after visiting the tanning salon.
Therefore, the appropriate tanning device is to be selected depending on the desired tanning goal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
Clinical studies on the bundled uwe sun tanning beds/booths were not required in order to demonstrate the safety, effectiveness and performance of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
uwe sun tanning beds/booths
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing right, with a design that resembles a bird or wing above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2016
PC Marketing, Inc. c/o Shepard Bentley, RAC Bentley Biomedical Consulting, LLC 28241 Crown Valley Parkway, Suite 510(k) Laguna Niguel, CA 92677
Re: K153479
Trade/Device Name: uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet lamp for tanning Regulatory Class: Class II Product Code: LEJ Dated: March 13, 2016 Received: March 17, 2016
Dear Mr. Bentley:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in 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" (21CFR 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
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Indications for Use
510(k) Number (if known) K152364
Device Name
uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
Indications for Use (Describe) Intended to provide ultraviolet light to tan the 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Section 5
510(k) Summary
| Name and address
of submitter: | PC Marketing, Inc.
1040 Wilt Avenue
Ridgefield, NJ 07657
Phone: (201) 943 – 6100
Fax: (201) 943 - 4234
www.pctan.com |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Shepard Bentley, RAC
Bentley Biomedical Consulting, LLC
28241 Crown Valley Parkway, Suite 510(k)
Laguna Niguel, CA 92677
Phone: (949) 374 - 9187
Fax: (949) 606 - 8191
Email: sbentley@bentleybiomed.com |
| Date of submission: | 20 August, 2015 |
| Trade name of the device: | The bundle of uwe sun tanning beds/booths consists of:
• P90
• iBED EVG
• iSUN HP
• SILVERBULLET SE
• LOTUS |
| Common name of the device: | uwe sun tanning beds/booths (bundled) |
| Classification reference: | 21 CFR 878.4635 |
| Product code: | LEJ |
| Predicate Devices: | uwe sun tanning beds/booths |
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5.1 DEVICE DESCRIPTION
5.2 Intended Use
Intended to provide ultraviolet light to tan the skin.
5.2.1 Device Components
The uwe sun tanning beds/booths consist of several essential parts. These parts differ between the bed and the booth models.
The beds consist of a lying area and a canopy. The booth consists of a cabin and a door. Both sunlamp products contain the same electronic components like the main board and the relay board, fans, lamps etc.
The most significant differences are the decorating design elements and the implemented features like "Body Mist" and "Aroma". These constitute the several looks of the beds and booths.
The primary technical components of a tanning device are an artificial source of UV radiation, a variety of filters and reflectors as well as a mechanical structure with a defined active surface. Different tanning results can be achieved in varying strength tanning devices. This is due to the different strength UV lamps and the different UV-A and UV-B proportions of the UV radiation.
The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly, the UV-B radiation is primarily responsible for more long-term tanning results.
The disadvantage of the UV-B radiation is that the tan does not become visible until one or two days after visiting the tanning salon.
Therefore, the appropriate tanning device is to be selected depending on the desired tanning goal.
5
5.2.2 Comparison to Predicate Devices and Summary of Differences
Prior to September 2, 2014, the basic ultraviolet sunlamps named in this 510(k) existed and were offered for sales as legally marketed Class I 510(k)-exempt medical devices.
For the basis of this 510(k), PC Marketing, Inc. claims substantial equivalence to these legally marketed devices. Since none of the sun tanning booths named in this 510(k) have changed in 1) intended use or 2) technological design characteristics after September 2, 2014, essentially the contemporary sun tanning booths are identical to the predicate devices (i.e., those basic sun tanning booths offered for sale prior to the FDA's cutoff date of Sept. 2, 2014).
Such an approach of using the legally marketed Class I medical devices as predicated in the Final Reclassification Order published on June 2, 2014 in the Federal Register Vol. 79, No. 105, Page 31212, whereby it stated that:
"FDA cleared several 510(k)s for sunlamp products prior to exempting the devices from premarket notification submission. At least one 510(k) for a sunlamp product has cleared since then under product code LEJ. These cleared sunlamp products, as well as 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 predicates for substantial equivalence purposes."
This 510(k) provides ample evidence that the subject devices all have the same intended uses and substantially equivalent technological characteristics with each other, and conform to the special controls required by the reclassification order.
In short, the sun tanning booths described within this 510(k) submission are as safe and as effective as the predicate devices, as they are unchanged from their Class I configurations.
The devices differ in position, intensity, type and number of lamps. Related to these dimensions the duration until the maximum energy intensity and hence the maximum exposure time is reached, differs. The maximum exposure time factory preset. This set time cannot be exceeded by any other component. The maximum irradiance of all devices fulfill the requirements of FDA 21 CFR 1040.20.
The devices are equivalent to the predicate devices within the intended uses. which are identical, and the technological characteristics, which are nearly identical.
5.3 Discussion of Non-clinical Tests
The bundled uwe sun tanning beds/booths comply with the applicable safety and performance standards and therefore are safe and effective for their intended use. The devices have been thoroughly tested including electrical and thermal safety, electromagnetic compatibility, mechanical and environmental tolerance, environmental conditions, and functional verification and validation of specifications. The bundled uwe sun tanning beds/booths meet the requirements of the applicable FDA-recognized standards, specifically the IEC 60601-1:2005 and IEC 60601-1-2:2007 standards, and hazard analyses conforming to ISO 17491:2007 have been conducted to assure proper mitigations of risk of hazards leading to harm.
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The following quality assurance measures were applied to the bundled uwe sun tanning beds/booths:
- Risk Analysis ●
- . Requirements Review
- . Design Review
- Testing on unit level (Module verification) ●
- . Integration testing (System verification)
- . Final acceptance testing (Validation)
- . Performance testing
- . Safety testing
- Environmental testing
- . Usability testing
Discussion of Clinical Tests 5.4
Clinical studies on the bundled uwe sun tanning beds/booths were not required in order to demonstrate the safety, effectiveness and performance of the device.
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5.5 Conclusions demonstrating Safety, Effectiveness and Performance:
Based on its years of experience in the marketplace of the United States of America and the information provided in this submission, PC Marketing, Inc. concludes that the bundled uwe sun tanning beds/booths are safe, effective and substantially equivalent to the predicate devices.
End of 510(k) Summary