(210 days)
No
The device description and performance studies focus on the physical characteristics and safety standards of UV lamps, with no mention of AI or ML technology.
No
The product is intended for "cosmetic tanning of the human skin," which is not considered a therapeutic purpose.
No
Explanation: The device is explicitly stated to be for "cosmetic tanning of the human skin," and its description and performance studies focus on safety standards for UV lamps, not on diagnosing medical conditions.
No
The device description explicitly details physical components like bases, glass bulbs, electrodes, coatings, mercury, and inert fill gases, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "cosmetic tanning of the human skin using light between 260-400nm." This is a cosmetic or therapeutic application, not a diagnostic test performed on samples taken from the body (in vitro).
- Device Description: The description details a UV lamp for tanning, which is a physical device used externally on the body. IVD devices typically involve reagents, instruments, and software for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
The device is clearly intended for a non-diagnostic purpose related to altering the appearance of the skin.
N/A
Intended Use / Indications for Use
This product is intended for the exclusive purpose of cosmetic tanning of the human skin using light between 260-400nm.
Product codes
LEJ
Device Description
Light Sources UV Lamps for Indoor Tanning devices are ultraviolet lamps that have the same basic technological features and the same intended use. The ultraviolet sunlamps in this submission are classified either as low pressure, or high pressure devices. The main difference for the various models of sunlamps in this submission are: lamp wattage, lamp length, lamp diameter, and spectral emissions. Light Sources UV Lamps for Indoor Tanning devices are ultraviolet sunlamps classified either as low pressure, or high pressure devices emitting light between 260- 400nm. The basic parts are as follows: Bases, Glass Bulb (envelope), Electrodes (Cathodes/Coils), Phosphor Coating, Reflector Coating, Mercury, Inert fill gases.
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
Light Sources UV Lamps for Indoor Tanning Devices have been tested and conforms to INTERNATIONAL CONSENSUS STANDARDS: IEC/EN 61195:2014 (Double Capped Flourescnet Lamps Safety Specificattions) and IEC/EN 60355-2-27 (Household and Electrical Appliances Safety Requirements for Skin Exposure for UV and IR Radiation). Light Sources UV Lamps for Indoor Tanning Devices have been tested under and are in compliance with FDA PERFORMANCE STANDARDS: 21 CFR 1040.20 (Performance Standard For Sunlamp products and ultraviolet lamps intended for use in sunlamp products). Specific performance testing (spectral analysis) data is submitted in this application for each device that measured irradiance to ensure compliance with radiation limits set out in 21 CFR 1040.20. In addition to the standards above, Light Sources UV Lamps for Indoor Tanning Devices are designed and manufactured utilizing the following standards: QUALITY SYSTEM: ISO 13485:2012 Medical Devices, Quality Management System and ISO 9001:2008, Quality Management Systems.
Key Metrics
Not Found
Predicate Device(s)
*All devices listed in Section I of this submission., K901324, K883952, K874889, K870167, K854004, K853545
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, with flowing lines suggesting hair or fabric. The profiles are arranged in a way that they appear to be connected. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
LIGHT SOURCES INCORPORATED Ms. Susan Anthony-DeWet FDA Listing Consultant 37 Robinson Boulevard Orange, Connecticut 06477
December 17, 2015
Re: K151370 Trade/Device Name: UV Lamps for Indoor Tanning Devices Regulation Number: 21 CFR 878.4635 Regulation Name: Sunlamp products and ultraviolet lamps intended for use in sunlamp products Regulatory Class: Class II Product Code: LEJ Dated: November 16, 2015 Received: November 20, 2016
Dear Ms. Anthony:
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 Parts 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.
For
Sincerelv vours.
Joshua C. Nipper -S
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
510(k) Number (if known) K151370
Device Name
UV Lamps for Indoor Tanning Devices
Indications for Use (Describe)
This product is intended for the exclusive purpose of cosmetic tanning of the human skin using light between 260-400nm.
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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510(k) Summary
K151370
This 510(k) summary is being submitted in accordance of the requirements of 21 CFR Part 807.92
Date Prepared May 15, 2015
-
- Correspondent Information: AEGIS Regulatory, Inc. Susan Anthoney-DeWet 2424 Dempster Drive Coralville, IA 52241 Tel.: 865-982-5552 Email: sue@fdalistingconsultants.com
| On behalf of Sponsor: | Light Sources, Inc., |
|---|---|
| 37 Robinson Boulevard, Orange, CT. 06477 | |
| Contact: Eugene Czako, Sales Engineer | |
| Phone: 203-799-7877 X 3136 Fax: 203-795-5267 | |
| Email: gczako@light-sources.com |
2. General Information:
-
2.1 Device: UV Lamps for Tanning
2.2 Regulation Description: Sunlamp products and ultraviolet lamps intended for use in sunlamp products. -
2.3 Common/Usual Name: UV Sunlamp
Proprietary Names: Light Sources UV Lamps for Indoor Tanning Devices-2.4 Over 200+ Various Models (Master List included in submission contains models and Private Label names) -
2.5 Classification: Class II
-
2.6 Classification Number: 878.4635
-
2.7 Product Code: LEJ
-
2.8 Performance Standard: 21 CFR 1040.20
-
2.9 Requlation Medical Specialty: General and Plastic Surgery
3. Device Description:
Light Sources UV Lamps for Indoor Tanning devices are ultraviolet lamps that have the same basic technological features and the same intended use. The ultraviolet sunlamps
4
in this submission are classified either as low pressure, or high pressure devices. The main difference for the various models of sunlamps in this submission are: lamp wattage, lamp length, lamp diameter, and spectral emissions.
Light Sources UV Lamps for Indoor Tanning devices are ultraviolet sunlamps classified either as low pressure, or high pressure devices emitting light between 260- 400nm.
The basic parts are as follows:
- Bases ●
- Glass Bulb (envelope) ●
- Electrodes (Cathodes/Coils) ●
- Phosphor Coating ●
- Reflector Coating
- Mercury .
- . lnert fill gases
4. Intended Use:
Light Sources UV Lamps for Indoor Tanning devices are intended for the exclusive purpose of cosmetic tanning of the human skin using light between 260- 400nm.
5. Predicate Device (s):
The proposed devices are substantially equivalent to the following predicate devices,
which are currently in safe and effective commerce:
Primary Predicate Device: *All devices listed in Section I of this submission.
Secondary Predicate Devices:
-
- UV Sunlamp 95 UF-11 Light Sources, Inc K901324 1990
-
- UV Sunlamp 95 UF-11 Light Sources, Inc K883952 1988
-
- UV Sunlamp 95 UF-11 Light Sources, Inc K874889 1987
-
- UV Sunlamp 95 UF-11 Light Sources, Inc K870167 1987
-
- UV Sunlamp 95 UF-11 Light Sources. Inc K854004 1985
-
- UV Sunlamp 95 UF-11 Light Sources, Inc K853545 1985
*All of the devices included in this submission existed and were 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:
5
The reclassification order Federal Register Volume 79. Number 105 (Monday, June 2. 2014)] (see section N under FDA response 16) states that "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)".
The primary predicate devices are identical to the proposed devices and no differences exist between the devices. The primary predicate devices existed and were legally marketed prior to September 2, 2014, a list of FDA accession numbers is included in this submission.
The secondary predicate devices differ from the proposed devices in that the proposed devices have additional safety features and newer components but have the same intended use as the secondary predicate devices; have the same technological characteristics as the secondary predicate devices and conform to the special controls required by the reclassification order.
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 device and the predicate device listed in section 5 of this summary.
7. Performance Data:
Light Sources UV Lamps for Indoor Tanning Devices have been tested and conforms to
INTERNATIONAL CONSENSUS STANDARDS:
- . IEC/EN 61195:2014 (Double Capped Flourescnet Lamps Safety Specificattions)
- IEC/EN 60355-2-27 (Household and Electrical Appliances Safety Requirements ● for Skin Exposure for UV and IR Radiation).
Light Sources UV Lamps for Indoor Tanning Devices have been tested under and are in compliance with
FDA PERFORMANCE STANDARDS:
- 21 CFR 1040.20 (Performance Standard For Sunlamp products and ultraviolet . lamps intended for use in sunlamp products)
Specific performance testing (spectral analysis) data is submitted in this application for each device that measured irradiance to ensure compliance with radiation limits set out in 21 CFR 1040.20.
In addition to the standards above, Light Sources UV Lamps for Indoor Tanning Devices are designed and manufactured utilizing the following standards:
QUALITY SYSTEM:
- ISO 13485:2012 Medical Devices, Quality Management System .
- ISO 9001:2008, Quality Management Systems .
6
Conclusion
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 device and the predicate device(s) listed in section 5 of this summary. Therefore, substantial equivalency is requested.