(427 days)
KBL 6800 alpha, KBL 7900 alpha, KBL 4800 alpha, KBL 5600 alpha, KBL Tower Space 2000, KBL Tower Space 3000, KBL Tower pure Energy 5.0
Not Found
No
The device description and performance studies focus on the physical components, light emission, and safety testing of a tanning device, with no mention of AI or ML technologies.
No
The intended use of the device is for tanning of human skin, not for treating a disease or condition.
No
Explanation: The device is described as an over-the-counter tanning device intended for tanning human skin by emitting UV light, not for diagnosing any medical condition or disease.
No
The device description clearly states it consists of a mechanical structure equipped with artificial light sources, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The KBL Sunlamp Products described are used for tanning of the human skin by emitting UV light directly onto the body. They do not involve the analysis of any specimens taken from the body.
- Intended Use: The stated intended use is "tanning of the human skin," which is a cosmetic or aesthetic purpose, not a diagnostic one.
The description clearly indicates a device that interacts directly with the living human body for a non-diagnostic purpose.
N/A
Intended Use / Indications for Use
KBL Sunlamp Products are over-the-counter tanning devices emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning of the human skin of an adult person.
Product codes (comma separated list FDA assigned to the subject device)
LEJ
Device Description
KBL Sunlamp Products are whole-body tanning devices basically consisting of a mechanical structure equipped with artificial light sources producing ultraviolet light in the UVA and UVB region of the light spectrum.
The UV light is intended for irradiation of any part of the living human body to induce skin tanning. The UVA light primarily generates a superficial tan which appears rapidly and is intensive but also fades more rapidly whereas the UVB light generates more long term tanning results.
The user is either standing in the middle of the KBL Sunlamp Product if it is a vertical device (tanning tower) or lying on a bench if it is a horizontal device (tanning bed).
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
adult person
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 following non-clinical performance tests were performed for all proposed KBL sunlamp products:
- Biocompatibility testing in accordance with DIN EN ISO 10993-1:2010-04; DIN EN ISO 10993-5:2009-10; DIN EN ISO 10993-12:2012-10;
- Electrical and mechanical safety testing according to IEC 60601-1 Ed 3.1 2012/08 (IEC 60335-1:2010, 5te ed. and UL482:2005/09/02 Ed.9 Rev. 2013/10/03)
- Electromagnetic compatibility testing in compliance with IEC 60601-1-2:2007, modified. ●
- Spectral emission measurement based on the test procedure for measuring the spectral emission in accordance to IEC 60335-2-27:2009, 5th ed.
- Software verification and validation testing according to FDA's Guidance for Industry and ● FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
- Performance Standards testing in accordance with 21 CFR 1040.20
- Irradiance ratio limits are in accordance with 21 CFR 1040.20(c)(1). .
- Maximum timer intervals and exposure schedules have been determined according to FDA's "Policy on maximum timer interval and exposure schedule for sunlamp products".
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.
KBL 6800 alpha, KBL 7900 alpha, KBL 4800 alpha, KBL 5600 alpha, KBL Tower Space 2000, KBL Tower Space 3000, KBL Tower pure Energy 5.0
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 seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of three intertwined human profiles facing to the right, symbolizing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2016
KBL AG Mr. Norbert Becker Head of Technical Department Ringstrasse 24-26 Dernbach, Rheinland-Pfalz, Germany 56307
Re: K151962
Trade/Device Name: KBL Sunlamp Products Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet lamp for tanning Regulatory Class: Class II Product Code: LEJ Dated: September 12, 2016 Received: September 14, 2016
Dear Mr. Becker:
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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803); good manufacturing practice requirements as set 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 Parts 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/Resourcesfor You/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,
Christopher J. Ronk -S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K151962
Device Name
KBL Sunlamp Products
Indications for Use (Describe)
KBL Sunlamp Products are over-the-counter tanning devices emitting ultraviolet light in the UVB and
UVA region of the spectrum intended for tanning of the human skin of an adult person.
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
Page 1 of 1
PSC Publishing Services (301) 443-5740
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Image /page/3/Picture/0 description: The image shows the logo for KBL AG, which is "The Beauty & Health Company". The logo consists of a yellow circle with white lines inside, followed by the letters "KBL" in gray. The letters "AG" are in a smaller font and are located to the right of the "L". A yellow line is underneath the letters, and the text "The Beauty & Health Company" is underneath the yellow line.
510(k) SUMMARY
(according to 21 CFR 807.92)
1. GENERAL INFORMATION
| Submitter: | KBL AG
Ringstrasse 24-26
56307 Dernbach, GERMANY
Phone: +49 (0) 2689 9426-0
Fax: +49 (0) 2689 9426-66 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Norbert Becker
Ringstrasse 24-26
56307 Dernbach, GERMANY
Phone: +49 (0) 2689 9426-525
Fax: +49 (0) 2689 9426-500
E-mail: nbecker@kbl.de |
2. PROPOSED DEVICE(S)
Preparation date:
| Device Bundling Name: | KBL Sunlamp Product |
|---|---|
| Trade Name(s): | KBL 6800 alpha / KBL 7900 alpha |
| KBL 4800 alpha / KBL 5600 alpha | |
| KBL Tower Space 2000 / KBL Tower Space 3000 | |
| KBL Tower pure Energy 5.0 | |
| Common Name | Tanning device |
| Classification Name: | Sunlamp product (21 CFR 878.4635, Product Code LEJ) |
June 8, 2015
All Proposed Devices have originally been listed as Class I devices (510(k)-exempt sunlamp products) and legally offered for sale before September 2, 2014. In accordance with the Final Order (Federal Register, Volume 79, Number 5) the proposed devices are used as Predicate Devices for Substantial Equivalence purposes.
4
Image /page/4/Picture/0 description: The image shows the logo for KBL AG, a beauty and health company. The logo features a yellow circle with white lines inside, followed by the letters "KBL" in gray. Below the letters is a yellow line, and below that is the text "The Beauty & Health Company" in gray.
3. PREDICATE DEVICE(S)
| Trade Name(s): | KBL 6800 alpha / KBL 7900 alpha
KBL 4800 alpha / KBL 5600 alpha
KBL Tower Space 2000 / KBL Tower Space 3000
KBL Tower pure Energy 5.0 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Tanning device |
| Classification Name: | Sunlamp product (21 CFR 878.4635, Product Code LEJ) |
4. DEVICE DESCRIPTION
KBL Sunlamp Products are whole-body tanning devices basically consisting of a mechanical structure equipped with artificial light sources producing ultraviolet light in the UVA and UVB region of the light spectrum.
The UV light is intended for irradiation of any part of the living human body to induce skin tanning. The UVA light primarily generates a superficial tan which appears rapidly and is intensive but also fades more rapidly whereas the UVB light generates more long term tanning results.
The user is either standing in the middle of the KBL Sunlamp Product if it is a vertical device (tanning tower) or lying on a bench if it is a horizontal device (tanning bed).
5. INDICATIONS FOR USE
The Indications for use for the Proposed Devices are identical to the Predicate Devices as shown in Table 1 below:
Table 1
| Proposed Device | Predicate Device |
|---|---|
| KBL Sunlamp Products are over-the-counter tanning devices emitting ultraviolet light in the UVA and UVB region of the spectrum intended for tanning of the human skin of an adult person. | KBL Sunlamp Products are over-the-counter tanning devices emitting ultraviolet light in the UVA and UVB region of the spectrum intended for tanning of the human skin of an adult person. |
5
Image /page/5/Picture/0 description: The image shows the logo for KBL AG, "The Beauty & Health Company". The logo consists of a yellow circle with white lines inside, followed by the letters "KBL" in gray. The letters "AG" are in smaller font and are located to the right of the "L". Below the letters is a yellow line, and below that is the text "The Beauty & Health Company".
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
We believe that the Technological Characteristics of the Proposed Devices in comparison to the Predicate Devices show that they are substantially equivalent (Table 2).
| Brand and type name ↓ | Number of Lamps Canopy | Watts | Number of Lamps Bench | Watts | Number of Facial Lamps | Watts | Number of Shoulder Lamps | Watts | Max. Exposure time in min | Dimentions in inches (height x width x depth) |
|---|---|---|---|---|---|---|---|---|---|---|
| Proposed Device | ||||||||||
| KBL 6800 alpha | 26 / 0 or | |||||||||
| 20 / 6 or | ||||||||||
| 24 / 2 | 160 / 80 | 20 | 180 | 4 | 600 | 2 | 250 | 10 | when closed: | |
| ~60,39" x ~93,70" x ~56,30" | ||||||||||
| when open: | ||||||||||
| ~76,46" x ~93,70" x ~56,30" | ||||||||||
| Predicate Device | ||||||||||
| KBL 6800 alpha | 26 / 0 or | |||||||||
| 20 / 6 or | ||||||||||
| 24 / 2 | 160 / 80 | 20 | 180 | 4 | 600 | 2 | 250 | 10 | when closed: | |
| ~60,39" x ~93,70" x ~56,30" | ||||||||||
| when open: | ||||||||||
| ~76,46" x ~93,70" x ~56,30" | ||||||||||
| Proposed Device | ||||||||||
| KBL 7900 alpha | 20 / 6 | 160 / 80 | 24 | 180 | 4 | 600 | 2 | 250 | 10 | when closed: |
| ~67,44" x ~93,70" x ~56,30" | ||||||||||
| when open: | ||||||||||
| ~82,16" x ~93,70" x ~56,30" | ||||||||||
| Predicate Device | ||||||||||
| KBL 7900 alpha | 20 / 6 | 160 / 80 | 24 | 180 | 4 | 600 | 2 | 250 | 10 | when closed: |
| ~67,44" x ~93,70" x ~56,30" | ||||||||||
| when open: | ||||||||||
| ~82,16" x ~93,70" x ~56,30" | ||||||||||
| Proposed Device | ||||||||||
| KBL 4800 alpha | 22 / 2 | 160 / 80 | 16 | 180 | 3 | 500 | N/A | N/A | 12 | when closed: |
| ~53,94 x ~91,74 x ~62,21 | ||||||||||
| when open: | ||||||||||
| ~67,33 x ~91,74 x ~56,70 | ||||||||||
| Predicate Device | ||||||||||
| KBL 4800 alpha | 22 / 2 | 160 / 80 | 16 | 180 | 3 | 500 | N/A | N/A | 12 | when closed: |
| ~53,94 x ~91,74 x ~62,21 | ||||||||||
| when open: | ||||||||||
| ~67,33 x ~91,74 x ~56,70 | ||||||||||
| Proposed Device | ||||||||||
| KBL 5600 alpha | 24 / 2 | 160 / 80 | 16 | 180 | 4 | 500 | N/A | N/A | 12 | when closed: |
| ~58,27 x ~91,74 x ~63,39 | ||||||||||
| when open: | ||||||||||
| ~70,87 x ~91,74 x ~56,70 | ||||||||||
| Predicate Device | ||||||||||
| KBL 5600 alpha | 24 / 2 | 160 / 80 | 16 | 180 | 4 | 500 | N/A | N/A | 12 | when closed: |
| ~58,27 x ~91,74 x ~63,39 | ||||||||||
| when open: | ||||||||||
| ~70,87 x ~91,74 x ~56,70 | ||||||||||
| Proposed Device | ||||||||||
| KBL Tower space 2000 | 50 | 180 | N/A | N/A | N/A | N/A | N/A | N/A | 11 | when closed: |
| 85.83 x 55.12 x 55.31 | ||||||||||
| when open: | ||||||||||
| 85.83 x 55.12 x 77.28 | ||||||||||
| Predicate Device | ||||||||||
| KBL Tower space 2000 | 50 | 180 | N/A | N/A | N/A | N/A | N/A | N/A | 11 | when closed: |
| 85.83 x 55.12 x 55.31 | ||||||||||
| when open: | ||||||||||
| 85.83 x 55.12 x 77.28 |
Table 2
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Image /page/6/Picture/0 description: The image shows the logo for KBL AG, a beauty and health company. The logo features a yellow circle with lines inside, followed by the letters "KBL" in gray. Below the letters is a yellow line, and below that is the text "The Beauty & Health Company" in gray.
| Proposed
Device
KBL Tower
space 3000 | 52 | 180 | N/A | N/A | N/A | N/A | N/A | N/A | 11 | when closed:
85.83 x 55.12 x 58.98
when open:
85.83 x 55.12 x 77.09 |
|----------------------------------------------------|----|-----|-----|-----|-----|-----|-----|-----|----|------------------------------------------------------------------------------|
| Predicate
Device
KBL Tower
space 3000 | 52 | 180 | N/A | N/A | N/A | N/A | N/A | N/A | 11 | when closed:
85.83 x 55.12 x 58.98
when open:
85.83 x 55.12 x 77.09 |
| Proposed
Device
KBL Tower
pureEnergy 5.0 | 52 | 200 | N/A | N/A | N/A | N/A | N/A | N/A | 10 | when closed:
93,23 x 54,93 x 48,55
when open:
93,23 x 54,93 x 72,56 |
| Predicate
Device
KBL Tower
pureEnergy 5.0 | 52 | 200 | N/A | N/A | N/A | N/A | N/A | N/A | 10 | when closed:
93,23 x 54,93 x 48,55
when open:
93,23 x 54,93 x 72,56 |
7. PERFORMANCE DATA
The following non-clinical performance tests were performed for all proposed KBL sunlamp products:
- . Biocompatibility testing in accordance with DIN EN ISO 10993-1:2010-04; DIN EN ISO 10993-5:2009-10; DIN EN ISO 10993-12:2012-10;
- . Electrical and mechanical safety testing according to IEC 60601-1 Ed 3.1 2012/08 (IEC 60335-1:2010, 5te ed. and UL482:2005/09/02 Ed.9 Rev. 2013/10/03)
- Electromagnetic compatibility testing in compliance with IEC 60601-1-2:2007, modified. ●
- . Spectral emission measurement based on the test procedure for measuring the spectral emission in accordance to IEC 60335-2-27:2009, 5th ed.
- Software verification and validation testing according to FDA's Guidance for Industry and ● FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
- . Performance Standards testing in accordance with 21 CFR 1040.20
- Irradiance ratio limits are in accordance with 21 CFR 1040.20(c)(1). .
- . Maximum timer intervals and exposure schedules have been determined according to FDA's "Policy on maximum timer interval and exposure schedule for sunlamp products".
8. CONCLUSION
Based on an analysis of the technological characteristics, non-clinical performance data and indications for use, KBL AG believes that the Proposed Devices are substantially equivalent to the legally marketed Predicate Devices and do not raise any new issues of safety and effectiveness.