(113 days)
Not Found
No
The device description and performance studies focus solely on the physical characteristics and UV radiation output of a standard UV lamp for tanning, with no mention of AI or ML technologies.
No.
The device is intended for tanning human skin, not for treating any specific disease, injury, or condition. Therefore, it does not meet the definition of a therapeutic device.
No
The device is an ultraviolet lamp intended for tanning human skin, which is a cosmetic purpose, not for diagnosing a medical condition. While performance testing includes "spectral analysis" and "measurement of irradiance to verify compliance with radiation limits defined in 21CFR1040.20", this is for regulatory compliance and safety, not for diagnostic assessment of a patient or condition.
No
The device description clearly describes a physical ultraviolet lamp, which is a hardware component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "for use in sunlamp products for tanning of human skin." This is a direct application to the human body for a cosmetic purpose (tanning), not for the diagnosis of disease or other conditions based on in vitro examination of specimens derived from the human body.
- Device Description: The description details a UV lamp used in sunlamp products for tanning. It describes the physical characteristics and operation of the lamp, which is consistent with a device used for external application to the skin.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting markers of disease, or providing diagnostic information.
Therefore, based on the provided information, this device falls under the category of a sunlamp product component used for tanning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This ultraviolet lamp is intended for use in sunlamp products for tanning of human skin.
Product codes (comma separated list FDA assigned to the subject device)
LEJ
Device Description
The component ultraviolet lamp model family or part numbers are for use in sunlamp products to tan human skin. They fall into a generic class of UV lamps that have the same basic technological features, characteristics, except for power rating, diameter and length, with the exact same intended use. The UV sunlamp model family are for tanning human skin use. They vary in brand ID and unique lamp ratings accordingly. These sunlamps fit into a wavelength range of 200-710nm and operate from the end product ballast supply.
There are individual component sunlamps listed in the exhibit page. They are classified as low pressure, mercury rare gas discharge devices and generally have the same construction and technical principals of operation as that of a common fluorescent lamp. The UV lamps have a tubular glass envelope with internal surface coated with fluorescent phosphor. The sealed lamps include the composition and electrical means to activate the UV light within the wavelength specification. The construction is controlled by production procedures and test methods defined in the QMS. The UV radiation is controlled by these methods to assure safe use.
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)
The Feilo Sylvania UV lamps are intended for use in sunlamp products for tanning of human skin comply with the consensus standards and specifications listed below and are therefore validated as safe for the intended use. The device sunlamps are tested, validated and verification procedures are in place to confirm design specifications.
Specific performance testing (spectral analysis) data is submitted to CDRH for the component UV lamps with measurement of irradiance to verify compliance with radiation limits defined in 21CFR1040.20.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 22, 2018
Feilo Sylvania Germany GmbH % Steve Mlcoch President NATS Corp. PO Box 1257 30 Northport Rd. Sound Beach, New York 11789
Re: K180581
Trade/Device Name: UV Lamps for Sunlamp Products Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet Lamp For Tanning Regulatory Class: Class II Product Code: LEJ Dated: February 1, 2018 Received: March 1, 2018
Dear Steve Mlcoch:
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 device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
Expiration Date: 06/30/2020 See PRA Statement below.
Form Approved: OMB No. 0910-0120
510(k) Number (if known) K180581
Device Name
UV Lamps for Sunlamp Products
Indications for Use (Describe)
This ultraviolet lamp is intended for use in sunlamp products for tanning of human 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Scrvices (301) 443-4740 EF
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510(K) SUMMARY K180581 February 1, 2018
SUBMITTER INFORMATION:
Feilo Sylvania Germany GmbH Graf-Zeppelin-Str. 9 91056 Erlangen Germany
Contact: Achim Tonat Tel: 49-9131-793-242 Email:achim.tonat@feilosylvania
APPLICANT/FDA AGENT/CORRESPONDING OFFICIAL INFORMATION:
North American Technical Services (NATS) Corp. PO Box 1257 Sound Beach, NY 11789 Email: natscorp@aol.com Contact: Stephen T. Mlcoch
DEVICE NAME:
Common Name: Ultraviolet Sunlamps Proprietary Model: Component UV Sunlamp Model and Part Number Family per attachment page list
Classification: II Classification Code, Category: LEJ, 21CFR 878.4635, General & Plastic Surgery
DESCRIPTION:
The component ultraviolet lamp model family or part numbers are for use in sunlamp products to tan human skin. They fall into a generic class of UV lamps that have the same basic technological features, characteristics, except for power rating, diameter and length, with the exact same intended use. The UV sunlamp model family are for tanning human skin use. They vary in brand ID and unique lamp ratings accordingly. These sunlamps fit into a wavelength range of 200-710nm and operate from the end product ballast supply.
There are individual component sunlamps listed in the exhibit page. They are classified as low pressure, mercury rare gas discharge devices and generally have the same construction and technical principals of operation as that of a common fluorescent lamp. The UV lamps have a tubular glass envelope with internal surface coated with fluorescent phosphor. The sealed lamps include the composition and electrical means to activate the UV light within the wavelength specification. The construction is controlled by production procedures and test methods defined in the QMS. The UV radiation is controlled by these methods to assure safe use.
INTENDED USE:
The ultraviolet lamp is intended for use in sunlamp products for tanning human skin.
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PREDICATE DEVICES:
Many of the UV sunlamps listed in this 510K previously existed and were offered for sale as class I, 510K exempt medical devices before September 2, 2014. Feilo Sylvania has merged and taken ownership of the Havells Sylvania Germany factory and business including product CDRH submissions by SLI Lichtsysteme GmbH. The model part numbers and brand names added all sustain equivalent construction, characteristics and safe performance. Essentially the newest UV lamps are identical to the sunlamps made at the same location controlled by Havells and substantially equivalent to the other predicate devices cited. All sunlamps listed, now controlled by Feilo Sylvania Germany, have the same intended use, sustain the same technological characteristics and are validated as safe and effective using the control methods and standards testing applied to the designed construction and production.
The predicate devices identified are:
-
- Havells Sylvania Germany/ SLI Lichtsysteme GmbH - These companies produced class I 510K exempt UV sunlamps prior to September 2, 2014 of constructions now owned and controlled by Feilo Sylvania Germany at the same Havells location in Erlangen, Germany
- K152273 Cosmedico Light, Inc., dated October 30, 2015 2.
- K151370 Light Sources Incorporated dated December 17, 2015 3.
The listed UV sunlamps devices made by Feilo Sylvania at the previously owned Havells location, have the same control methods and compliance validation. Brand names added, with part number identifications, have the same technological features and intended use. Cosmedico Light and Light Sources have equivalent over the counter UV sunlamps with the same indications of use. Generally, the constructions are equivalent and are validated as safe and effective.
The fundamental comparison information about critical feature to the predicate devices cited are:
| FEATURE | FEILO SYLVANIA | HAYELLS, SLI | COSMEDICO | LIGHT SOURCES |
|---|---|---|---|---|
| Factory: | Erlangen Germany | / Erlangen Germany | / Cosmedico | / Light Sources |
| Code/K | LEJ, K180581 | / LEJ 9-2-14 exempt | /LEJ, K152273 | /LEJ, K151370 |
| Indication: | UV light to tan skin | / UV light to tan skin | /UV light to tan skin | / UV light to tan skin |
| Biocompatibility: | no contact | / no contact | / no contact | / no contact |
| Power Source | Ballast | / Ballast | / Ballast | / Ballast |
| Tech Specs: | wavelength* | |||
| UVA, UVB | ||||
| Florescent | / same specs* | / equivalent* | ||
| Florescent | / equivalent* | |||
| Radiation | 21CFR1040.20 | / Accession #s | /CDRH compliant | /CDRH compliant |
| Havells, SLI records | ||||
| F Sylvania | 0720172-00 | |||
| 1810251-00 |
*The standard visual range of fluorescent lamps is 380nm-760nm. The UV radiation range is 300nm - 400nm. These lamps emit their energy closest to the visible range 320nm - 400nm, with the emission spectrum range of 260nm - 320mm containing a relative amount of UVB radiation. Feilo Sylvania and all predicate companies comply to the same consensus and industry standards and have equivalent QMS control activity.
PERFORMANCE DATA AND DESIGN CONTROL ACTNITIES:
The Feilo Sylvania UV lamps are intended for use in sunlamp products for tanning of human skin comply with the consensus standards and specifications listed below and are therefore validated as safe for the intended use. The device sunlamps are tested, validated and verification procedures are in place to confirm design specifications. Compliance with the following mandatory and voluntary standards is a QMS requirement:
INTERNATIONAL CONSENSUS STANDARDS AND APPLIED SPECIFICATIONS:
- . IEC/EN 61195:2014 - Double Capped Florescent Lamps Safety Specifications
- . IEC/EN 60355-2-27:2013 - Particular Appliances Safety Requirements for Skin Exposure to UV and IR Radiation
- EN60081:1998 - Double Capped Fluorescent Lamps - Performance Specifications
- . EN61228:2008 - Fluorescent Ultraviolet Lamps Used for Tanning. Measurement and Specification Method
- . EN62471:2008- Photobiological Safety of Lamps and Lamp Systems
- . EN50581: 2012 - Technical Documentation for the Assessment of Electrical and Electronic with Respect to the Restriction of Hazardous Substances
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FDA PERFORMANCE REFERENCE SPECIFICATION:
- o 21CFR 1040.20 - Performance standard for sunlamp products and ultraviolet lamps intended for the use in sunlamp products
Specific performance testing (spectral analysis) data is submitted to CDRH for the component UV lamps with measurement of irradiance to verify compliance with radiation limits defined in 21CFR1040.20.
QUALITY MANAGEMENT SYSTEM COMPLIANCE:
- ISO9001 Quality Management System
Accordingly, factory procedures are established for production, assembly and testing. The control activity shows that there are no new questions of safety and effectiveness for the described UV Sunlamps. The design analysis and predicate comparison confirm the functional characteristics are the same to the predicate devices and raise no other safety or effectiveness issues. Inspection verification procedures assure performance concerns are compliant to QMS specifications.
CONCLUSION:
The Feilo Sylvania UV lamp is intended for use in sunlamp products for tanning of human skin. Each are the same or substantially equivalent to the predicate device sunlamps. They have the same intended use. Havells had FDA/CDRH registration# 1000553841 and SLI had registration #1000533299. They also have a history of UV reporting acknowledged by many related Accession #s that are now part of the Feilo Sylvania compliance records and data. The key comparisons and analysis of the safety, indications, specific use, performance, design, construction, material composition, energy source, power output, technological propelties, skin tan treatments, compliance testing, previous production history and method of operation, the manufacturer Feilo Sylvania verified that no significant differences exist between these device sunlamps and the predicated devices listed. Therefore, substantial equivalence exists.
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