(413 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical components, electrical safety, and software validation for controlling the tanning lamps, with no mention of AI or ML technologies.
No
The intended use of the device is for tanning the skin, which is not a therapeutic purpose.
No
The device is a sunlamp product intended for tanning the skin, not for diagnosing any medical condition. Its function is to emit UV light for cosmetic purposes.
No
The device description clearly details physical hardware components such as lamps, filters, metal frames, and plastic panels. While software is mentioned for control and safety features, the device is fundamentally a hardware-based sunlamp product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The stated intended use is "Sunlamp product intended for use to tan the skin." This is a cosmetic or aesthetic purpose, not a diagnostic one.
- Device Description: The descriptions detail the physical components and operation of tanning beds and booths, focusing on lamps, filters, and safety features. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does none of those things.
- Performance Studies: The performance studies focus on conformity with performance standards for sunlamp products, usability for OTC use, biocompatibility of materials in contact with skin, electrical safety, and software validation. These are not the types of studies conducted for IVD devices, which would typically involve clinical performance studies evaluating diagnostic accuracy (sensitivity, specificity, etc.).
In summary, the device is clearly intended for tanning the skin and its description and testing align with a non-diagnostic device.
N/A
Intended Use / Indications for Use
Sunlamp product intended for use to tan the skin.
Product codes (comma separated list FDA assigned to the subject device)
LEJ
Device Description
HPO Exotic: This model is a high pressure stand up appliance with tanning lamps located in four vertical columns. The high pressure lamps have a double filter: one blue cobalt filter in the inner part and one acrylic filter in the outer. The 1000 W lamps have an additional clear glass filter between the blue filters and the acrylic. The body frame is all in metal and it closes where it is possible all the electrical components. The body frame is covered by plastic thermoformed panels.
LP1: These suntan beds are three models with the same frame, aesthetic and with many common electrical parts. All the beds use the same low pressure lamps, the difference is the presence or not of the facial lamps.
There are three versions:
LP1-32/32EL: suntan bed with only low pressure lamps, 16 in the canopy and 16 in the base
LP1-35/35EL: suntan bed with 16 low pressure lamps in the base and 16 low pressure lamps in the canopy. In the canopy is mounted one high pressure facial lamp.
LP1-45/45EL: suntan bed with 16 low pressure lamps in the base and 16 low pressure lamps in the canopy. In the canopy are mounted two high pressure facial lamps.
In all models the low pressure lamps are separated from the person by acrylic panels (3mm thickness for the canopy and 5mm thickness for the base). The high pressure lamps have a double glass filter, one blue cobalt filter in the inner part and one clear filter in the outer. Every blue filter has a control switch. If the door is opened during the session or the filters are removed, the control switch interrupts the power supply on the control board and all lamps switch off.
The body frame is all in metal and it closes where it is possible all the electrical components. The body frame is covered by plastic thermoformed panels.
LP2: This model is a bed with low pressure lamps in the base. The facial has 3 high pressure lamps. The low pressure lamps are separated from the person by acrylic panels (3mm thickness for the canopy and 5 mm thickness for the base). The high pressure lamps have a double glass filter: one blue cobalt filter in the inner part and one clear filter in the outer. Each blue filter has a control switch. If the door is opened during the session or the filter breaks the control switch interrupts the power supply and the lamp switches off.
LP3: These suntan beds are two models with the same frame, aesthetic and with many common electrical parts. The new models are similar to the current LP3, only the number of lamps was changed.
There are two models:
LP3-110: suntan bed with 42 low pressure lamps, 18 in the base and 24 in the canopy. The facial has four 600W (Kalfasun 630F) high pressure lamps.
LP3-140: suntan bed with 48 low pressure lamps, 20 in the base and 28 in the canopy. The facial has two 600W (Kalfasun 630F) and two 1500W (Kalfasun 1530F) high pressure lamps. Both models are beds with low pressure tanning lamps in the canopy and in the base and high pressure lamps in the facial area. The low pressure lamps are separated from the person by acrylic panels (3mm thickness for the canopy and 8mm thickness for the base). The high pressure lamps have a double glass filter: one blue cobalt filter in the inner part and one clear filter in the outer.
Mastersun: This model is a bed with a high pressure tanning lamps located in five horizontal columns placed around the person body. Three columns are in the canopy, and two are in the bed, under the acrylic panel (8mm thickness). The high pressure lamps have a double glass filter one blue cobalt filter in the inner part and one clear filter in the outer.
Vega: This model is a booth with low pressure lamps: the machine is mainly composed of three curved panels, two fixed and one is the door. Each panel has a set low pressure lamps separated from the person by acrylic panels.
The associated sunlamps include:
HPO Exotic: BLV - Germany MHLF 630 (Kalfasun 630 F) 23470401, BLV - Germany MHLF 1530 (Kalfasun 1530 F)23480601
LP1: BLV - Germany MHLF 630 (Kalfasun 630 F) 23470401, Lighttech - Hungary B23-S White 100W, Lighttech - Hungary B14-S White 100W, Cosmedico - Germany Cosmostar Longlife 100W
LP2: BLV - Germany MHLF 630 (Kalfasun 630 F) 23470401, Lighttech - Hungary B23-S White 100W, Lighttech - Hungary B25-S White 160W
LP3: BLV - Germany MHLF 630 (Kalfasun 630 F) 23470401, BLV - Germany HLF 1530 (Kalfasun 1530 F) 23480601, Lighttech - Hungary B23-S White 100W, Lighttech - Hungary B25-S White 160W
Mastersun: BLV - Germany MHLF 630 (Kalfasun 630 F) 23470401, BLV - Germany MHLF 640 (Kalfasun 640 F) 234720 01, BLV - Germany MHLF 1530 (Kalfasun 1530 F) 23480601, BLV - Germany MHLF 1540 (Kalfasun 1540 F) 234820
01 Vega: Lighttech - Hungary B23-S White 160W
The associated protective eyewear:
Ultra Sunglobes – World SunCare Products, Ltd – England
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 subject devices were tested to be in conformity with Performance Standard 21 CFR 1040.20. They are identical to the predicate.
Usability data is included with the submission to support the conversion of indications from Rx to OTC.
Biocompatibility testing: The subject devices are categorized as surface devices which only come into contact with intact skin for a duration of less than 24 hours. The only material that comes into contact with the patient's skin is the polymethyl methacrylate (PMMA), which has been shown to be biocompatible via European standard 30993 (which corresponds to ISO 10993). No additional biocompatibility testing was done, as the devices are identical to the predicate in every way.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on all devices, which were shown to pass the tests conducted. No additional electrical or electromagnetic testing was performed, as the devices are identical to the predicate in every way.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
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.
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.
No reference devices were used in this submission.
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 and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2017
Sportarredo Group S.C. % Rhonda Alexander Senior Regulatory Specialist Registrar Corp. 144 Research Dr. Hampton, Virginia 23666
Re: K161394
Trade/Device Name: HPO Exotic, Lp1, Lp2, Lp3, MasterSun 360, MasterSun 360 New Reflector, Vega Lux Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet Lamp For Tanning Regulatory Class: Class II Product Code: LEJ Dated: May 13, 2016 Received: May 19, 2016
Dear Rhonda Alexander:
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
1
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 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.
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) K161394
Device Name
HPO Exotic, LP1, LP2, LP3, MasterSun 360, MasterSun 360 New Reflector, Vega Lux
Indications for Use (Describe) Sunlamp product intended for use to tan the skin.
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary (21 CFR 807.92)
l. SUBMITTER
Sportarredo Group S.C. Via dell' Industria 7 Gruaro, Venice 30020 Italy
| Contact Person: | Stefano Iridio, Area Sales Manager (s.iridio@sportarredousa.com) |
|---|---|
| Phone Number: | +39 0421 767676 |
| Date Prepared: | April 15, 2016 |
II. DEVICE
| Names of Devices: | HPO Exotic
LP1
LP2
LP3
Mastersun 360
Mastersun 360 New Reflector
Vega Lux |
|-----------------------|---------------------------------------------------------------------------------------------|
| Common or Usual Name: | Booth, Sun Tan |
| Regulatory Class: | Class II |
| Product Code: | LEJ |
III. PREDICATE DEVICE
Per the special controls for these devices, the predicate devices which were legally offered for sale on or before September 2, 2014, but which were 510(k) exempt. Thus, the submitter has compared the subject devices to similar models of suntan beds, named as follows (along with the corresponding radiation safety report accession number):
| K152233 | |
|---|---|
| HPO (08-9921019) | |
| LP1 (9922711-002) | |
| LP2 (9721344-006) | |
| LP3 110-140 (9721344-005) | |
| Mastersun 360/Mastersun 360 new Reflector (15-9721345) | |
| Vega Lux Open (09-9921019) |
No reference devices were used in this submission.
| Prior Submissions: |
|---|
These devices were previously cleared under k-number K152233.
4
DEVICE DESCRIPTION HPO Exotic
This model is a high pressure stand up appliance with tanning lamps located in four vertical columns. The high pressure lamps have a double filter: one blue cobalt filter in the inner part and one acrylic filter in the outer. The 1000 W lamps have an additional clear glass filter between the blue filters and the acrylic. The body frame is all in metal and it closes where it is possible all the electrical components. The body frame is covered by plastic thermoformed panels.
LP1
These suntan beds are three models with the same frame, aesthetic and with many common electrical parts. All the beds use the same low pressure lamps, the difference is the presence or not of the facial lamps.
There are three versions:
LP1-32/32EL: suntan bed with only low pressure lamps, 16 in the canopy and 16 in the base LP1-35/35EL: suntan bed with 16 low pressure lamps in the base and 16 low pressure lamps in the canopy. In the canopy is mounted one high pressure facial lamp.
LP1-45/45EL: suntan bed with 16 low pressure lamps in the base and 16 low pressure lamps in the canopy. In the canopy are mounted two high pressure facial lamps.
In all models the low pressure lamps are separated from the person by acrylic panels (3mm thickness for the canopy and 5mm thickness for the base). The high pressure lamps have a double glass filter, one blue cobalt filter in the inner part and one clear filter in the outer. Every blue filter has a control switch. If the door is opened during the session or the filters are removed, the control switch interrupts the power supply on the control board and all lamps switch off.
The body frame is all in metal and it closes where it is possible all the electrical components. The body frame is covered by plastic thermoformed panels.
LP2
This model is a bed with low pressure lamps in the base. The facial has 3 high pressure lamps. The low pressure lamps are separated from the person by acrylic panels (3mm thickness for the canopy and 5 mm thickness for the base). The high pressure lamps have a double glass filter: one blue cobalt filter in the inner part and one clear filter in the outer. Each blue filter has a control switch. If the door is opened during the session or the filter breaks the control switch interrupts the power supply and the lamp switches off.
LP3
These suntan beds are two models with the same frame, aesthetic and with many common electrical parts. The new models are similar to the current LP3, only the number of lamps was changed.
5
There are two models:
LP3-110: suntan bed with 42 low pressure lamps, 18 in the base and 24 in the canopy. The facial has four 600W (Kalfasun 630F) high pressure lamps.
LP3-140: suntan bed with 48 low pressure lamps, 20 in the base and 28 in the canopy. The facial has two 600W (Kalfasun 630F) and two 1500W (Kalfasun 1530F) high pressure lamps. Both models are beds with low pressure tanning lamps in the canopy and in the base and high pressure lamps in the facial area. The low pressure lamps are separated from the person by acrylic panels (3mm thickness for the canopy and 8mm thickness for the base). The high pressure lamps have a double glass filter: one blue cobalt filter in the inner part and one clear filter in the outer.
Mastersun
This model is a bed with a high pressure tanning lamps located in five horizontal columns placed around the person body. Three columns are in the canopy, and two are in the bed, under the acrylic panel (8mm thickness). The high pressure lamps have a double glass filter one blue cobalt filter in the inner part and one clear filter in the outer.
Vega
This model is a booth with low pressure lamps: the machine is mainly composed of three curved panels, two fixed and one is the door. Each panel has a set low pressure lamps separated from the person by acrylic panels.
The associated sunlamps include:
| HPO Exotic: | BLV - Germany MHLF 630 (Kalfasun 630 F) 23470401
BLV - Germany MHLF 1530 (Kalfasun 1530 F)23480601 |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| LP1: | BLV - Germany MHLF 630 (Kalfasun 630 F) 23470401
Lighttech - Hungary B23-S White 100W
Lighttech - Hungary B14-S White 100W
Cosmedico - Germany Cosmostar Longlife 100W |
| LP2: | BLV - Germany MHLF 630 (Kalfasun 630 F) 23470401
Lighttech - Hungary B23-S White 100W
Lighttech - Hungary B25-S White 160W |
| LP3: | BLV - Germany MHLF 630 (Kalfasun 630 F) 23470401
BLV - Germany HLF 1530 (Kalfasun 1530 F) 23480601
Lighttech - Hungary B23-S White 100W
Lighttech - Hungary B25-S White 160W |
| Mastersun: | BLV - Germany MHLF 630 (Kalfasun 630 F) 23470401
BLV - Germany MHLF 640 (Kalfasun 640 F) 234720 01
BLV - Germany MHLF 1530 (Kalfasun 1530 F) 23480601
BLV - Germany MHLF 1540 (Kalfasun 1540 F) 234820 |
| 01 Vega: | Lighttech - Hungary B23-S White 160W |
6
The associated protective eyewear:
Ultra Sunglobes – World SunCare Products, Ltd – England
IV. INDICATIONS FOR USE
Sunlamp product intended for use to tan the skin.
V. SUMMARY OF COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATEDEWICE
The subject and predicate devices are identical.
VI. PERFORMANCE
The subject devices were tested to be in conformity with Performance Standard 21 CFR 1040.20. They are identical to the predicate.
Usability data is included with the submission to support the conversion of indications from Rx to OTC.
Biocompatibility testing
The subject devices are categorized as surface devices which only come into contact with intact skin for a duration of less than 24 hours. The only material that comes into contact with the patient's skin is the polymethyl methacrylate (PMMA), which has been shown to be biocompatible via European standard 30993 (which corresponds to ISO 10993).
No additional biocompatibility testing was done, as the devices are identical to the predicate in every way.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on all devices, which were shown to pass the tests conducted.
No additional electrical or electromagnetic testing was performed, as the devices are identical to the predicate in every way.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
7
VII. CONCLUSIONS
Since the subject and predicate devices are identical technologically, with few minor aesthetic differences, we conclude that the change in intended use from prescription to over-the-counter does not negatively affect a finding of substantial equivalence between the devices and predicates.