(1093 days)
K Number (NONE)
Not Found
No
The device description explicitly states "There is no software contained in the device." and the "Mentions AI, DNN, or ML" section is "Not Found".
No
The device is intended to stimulate a tanning response in the skin, which is a cosmetic purpose, not a therapeutic one.
No
Explanation: The "Intended Use / Indications for Use" states that the device is intended to "provide ultraviolet light for the purpose of stimulating a tanning response in the skin." This describes a therapeutic or cosmetic purpose, not a diagnostic one.
No
The device description explicitly states, "There is no software contained in the device." The device is a hardware-based tanning unit utilizing fluorescent lamps and a mechanical timer.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide ultraviolet light for the purpose of stimulating a tanning response in the skin." This is a physical effect on the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a sunlamp product that emits UV light. It doesn't mention any components or processes related to analyzing biological samples.
- Anatomical Site: The anatomical site is "skin," which is the target of the UV light, not a source of a sample for analysis.
- Performance Studies: The performance studies focus on the device's radiation output and the protective eyewear's transmittance, not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Fiji Sun Fluorescent Tanning Unit does not perform any such analysis.
N/A
Intended Use / Indications for Use
The Fiji Sun Fluorescent Tanning Unit device (FIJI Sun) is intended to provide ultraviolet light for the purpose of stimulating a tanning response in the skin.
Product codes (comma separated list FDA assigned to the subject device)
LEJ
Device Description
The FIJI Sun Fluorescent Tanning Unit (FIJI SUN) is a small tabletop sunlamp product which uses four Sperti brand ultraviolet lamps (model number: FRT20TI21BUHO) manufactured for KBD. The FIJI Sun Fluorescent Tanning Unit uses a mechanical timer with a maximum timer interval of 15 minutes and a minimum timer interval of one minute. The maximum timer interval error as a percent of that interval is +/- 6%. Output performance testing and FDA performance standards were used to determine the maximum timer interval and the recommended exposure schedule which is on the device labeling and in the user instructions. Two pair of protective eye wear are supplied with the device. The spectral transmittance to the eye of the protective eyewear is 0.0008 in the wavelength range from 200 nm to 320 nm and 0.0004 in the wavelength range from 320nm to 400 nm and is sufficient over the wavelengths greater that 400nm to enable the user to see clearly enough to reset the timer. In order for the product to fulfill its function it emits UV light In the wavelength range from 290 nm to 400 nm and the emission level is one SED (100 J/m²). The minimum use distance specified in the product labeling and the user instruction is 18 inches. Adequate directions for use, warnings and contraindications are included in user instructions provided with the device and in the device labeling. There is no software contained in the device. The device is sold as Over the Counter (OTC).
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)
The FijiSun Fluorescent Tanning Unit has been tested and is in conformance to the international consensus standard:
ELECTRICAL SAFETY:
Recognition Number 19-4: IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012 Medical Electrical Equipment -Part 1: General Requirements For Basic Safety And Essential Performance (lec 60601-1:2005, Mod). (General II (ES/EMC))
This device has also been tested under and is in compliance with performance standards that have been established for such devices under Section 1040.20 of the Federal Food, Drug, and Cosmetics Act.
- Specific performance testing (spectral analysis) was done on these devices to measure irradiance to ensure compliance with radiation limits set out in 21 CFR 1040.20.
- Specific performance testing was done on the included protective eyewear (goggles) to ensure spectral transmittance did not exceed the value limits set out in 21 CFR 1040.20 while enabling the user to see clearly enough to reset the timer.
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.
K Number (NONE)- *CDRH Accession Number 1120263-000
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 22, 2018
KDB Inc., d.b.a. Sperti Sunlamp Susan Anthoney FDA Consultant / Document Specialist 2424 Dempster Dr. Coralville, Iowa 52241
Re: K151721
Trade/Device Name: Fiji Sun Fluorescent Tanning Unit Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet Lamp For Tanning Regulatory Class: Class II Product Code: LEJ Dated: June 25, 2015 Received: June 25, 2015
Dear Susan Anthoney:
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 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 -S3
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) K151721
Device Name
Fiji Sun Fluorescent Tanning Unit (FIJI Sun)
Indications for Use (Describe)
The Fiji Sun Fluorescent Tanning Unit device (FIJI Sun) is intended to provide ultraviolet light for the purpose of stimulating a tanning response in the skin.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary (807.92)
K151721
Submission Date: March 18, 2018
-
- Submitter Information: AEGIS Regulatory, Inc. Susan Anthoney-DeWet 2424 Dempster Drive Coralville, IA 52241 Tel.: 865-982-5552 Email: sue@fdalistingconsultants.com
| For Manufacturer: | KBD, Inc. d/b/a Sperti Sunlamp
Attn: James Shepard
2550 American Ct.
Crescent Springs, KY. 41017 |
| ------------------- | ----------------------------------------------------------------------------------------------------------- |
|---|
General Information: 2.
- 2.1 Regulation Description: Ultraviolet lamp for tanning
- 2.2 Common/Usual Name: Booth, Suntan
- 2.3 Proprietary Names: FijiSun Fluorescent Tanning Unit (FIJI Sun)
- 2.4 Classification: Class II
- 2.5 Classification Number: 878.4635
- 2.6 Product Code: LEJ
3. Device Description:
The FIJI Sun Fluorescent Tanning Unit (FIJI SUN) is a small tabletop sunlamp product which uses four Sperti brand ultraviolet lamps (model number: FRT20TI21BUHO) manufactured for KBD. The FIJI Sun Fluorescent Tanning Unit uses a mechanical timer with a maximum timer interval of 15 minutes and a minimum timer interval of one minute. The maximum timer interval error as a percent of that interval is +/- 6%. Output performance testing and FDA performance standards were used to determine the maximum timer interval and the recommended exposure schedule which is on the device labeling and in the user instructions. Two pair of protective eye wear are supplied with the device. The spectral transmittance to the eye of the protective eyewear is 0.0008 in the wavelength range from 200 nm to 320 nm and 0.0004 in the wavelength range from 320nm to 400 nm and is sufficient over the wavelengths greater that 400nm to
4
enable the user to see clearly enough to reset the timer. In order for the product to fulfill its function it emits UV light In the wavelength range from 290 nm to 400 nm and the emission level is one SED (100 J/m²). The minimum use distance specified in the product labeling and the user instruction is 18 inches. Adequate directions for use, warnings and contraindications are included in user instructions provided with the device and in the device labeling. There is no software contained in the device. The device is sold as Over the Counter (OTC).
4. Intended/Indications for Use:
The Fiji Sun Fluorescent Tanning Unit device (FIJI Sun) is intended to provide ultraviolet light for the purpose of stimulating a tanning response in the skin.
5. Predicate Device:
The proposed device is substantially equivalent to the following predicate device:
- Predicate Device: FijiSun Fluorescent Tanning Unit (KBD, Inc.)
K Number (NONE)- *CDRH Accession Number 1120263-000,
*The device included in this submission existed and was legally marketed prior to September 2, 2014. FDA accession numbers are included in this submission. Federal Register Volume 79, Number 105 (Monday, June 2, 2014)) "Any sunlamp product or UV lamp intended for use in a sunlamp product legally marketed on or before September 2, 2014 ....can be used as a predicate device in a 510(k)".
6. Substantial Equivalence to Predicate Device:
The predicate device is identical to the proposed FijiSun Fluorescent Tanning Unit device and no significant differences exist between the devices.
After an analysis of the safety, indications, intended uses, performance features, design materials, chemical composition, energy source, power output, technological properties, treatment areas, treatment regimes and methods of operation, the manufacturer believes that no significant differences exist between the proposed device and the predicate device listed in section 5 of this summary.
7. Performance Standards:
The FijiSun Fluorescent Tanning Unit has been tested and is in conformance to the international consensus standard:
ELECTRICAL SAFETY:
Recognition Number 19-4: IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012 Medical Electrical Equipment -Part 1: General Requirements For Basic Safety And Essential Performance (lec 60601-1:2005, Mod). (General II (ES/EMC))
5
This device has also been tested under and is in compliance with performance standards that have been established for such devices under Section 1040.20 of the Federal Food, Drug, and Cosmetics Act.
- . Specific performance testing (spectral analysis) was done on these devices to measure irradiance to ensure compliance with radiation limits set out in 21 CFR 1040.20.
- . Specific performance testing was done on the included protective eyewear (goggles) to ensure spectral transmittance did not exceed the value limits set out in 21 CFR 1040.20 while enabling the user to see clearly enough to reset the timer.
Conclusion
After an analysis of the safety, indications, intended uses, performance features, design materials, chemical composition, energy source, power output, technological properties, and methods of operation, the manufacturer believes that no significant differences exist between the proposed device and the predicate device listed in section 5 of this summary. Therefore, substantial equivalency is requested.