(98 days)
Not Found
No
The device description and performance studies focus on UV radiation, electrical/mechanical safety, and software validation for timer control, with no mention of AI or ML technologies.
No
The device is described as a tanning bed system intended solely for cosmetic skin tanning, not for treating any disease or condition. The "Intended Use" explicitly states its purpose is "tanning of the human skin," which is a cosmetic function, not a therapeutic one.
No
Explanation: The device is described as a tanning bed system intended to provide cosmetic tanning of human skin through UV radiation, not to diagnose any condition.
No
The device description clearly states it consists of a mechanical frame with UV lamps, indicating it is a hardware device. While software verification and validation are mentioned, this is for software contained in the medical device, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide tanning of the human skin." This is a cosmetic or therapeutic purpose, not a diagnostic one.
- Device Description: The device description focuses on the physical components and how they deliver UV radiation to the human body for tanning. There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) which is a core characteristic of IVDs.
- Lack of IVD-Specific Information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples.
- Detection or measurement of analytes.
- Diagnostic claims or intended use for diagnosing, monitoring, or predicting disease.
- Performance metrics like sensitivity, specificity, etc., which are crucial for evaluating the accuracy of diagnostic tests.
The device is clearly intended for direct interaction with the human body to induce a physical change (tanning), which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
Tanning Bed Systems are intended to provide tanning of the human skin.
Product codes
LEJ
Device Description
The primary technical components of sunlamp products are whole body tanning devices consisting of a mechanical frame with Ultraviolet (UV) lamps providing an artificial source of UV radiation. The UV light is intended for irradiation of the human body to induce skin tanning. The user of the proposed devices device either lies in the horizontal tanning bed or stands in the vertical tanning booth.
Skin tanning varies with skin type and as the UV sources intensities with characteristic UV-A and UV-B proportions result in cosmetic tanning of the human skin.
The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but fades more rapidly. The UV-B radiation is primarily responsible for more longterm tanning results.
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
The proposed devices have been non clinically tested in accordance with:
- Biocompatibility and in accordance with DIN EN ISO 10993
- Electrical and mechanical safety in accordance with IEC 60601-1 (IEC 60335-2-27 and UL 482)
- EMC in accordance with IEC 60601-1-2 (CISPR 14-1 and 14-2)
- Spectral emissions of all sunlamp products were measured. The test procedure for measuring the spectral emission is in accordance with IEC 6033-2-27 and 21 CFR 1002, 1010 — 1050).
- Irradiance ratio limits of all proposed sunlamp products are in accordance with 21 CFR 1040.2(c)(1).
- Software verification & validation testing according to FDA's "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices"
- The maximum timer intervals and exposure schedules have been determined according to FDA's "Policy on maximum timer interval and exposure schedule for sunlamp products."
- Performance Standards testing in accordance with 21 CFR 1040.20
Key Metrics
Not Found
Predicate Device(s)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 10, 2018
ProSun International LLC Jennifer Henkemans COO- Chief Operating Officer 2442 23rd Street North Saint Petersburg, Florida 33713
Re: K181455
Trade/Device Name: ProSun sunlamp products, Luxura sunlamp products Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet Lamp For Tanning Regulatory Class: Class II Product Code: LEJ Dated: May 31, 2018 Received: June 4, 2018
Dear Jennifer Henkemans:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/ofpmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Lumina, Prosun, Luxura, Onyx, Jade, Sundream
Indications for Use (Describe)
Tanning Bed Systems are intended to provide tanning of the 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.
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."
3
1.5 — 510(k) Summary
NON-CONFIDENTIAL SUMMARY OF SAFETY and EFFECTIVENESS In accordance with the requirements of the Safe Medical Device Act, FDA 21 CFR 807.92(c), ProSun International, LLC herein submits this Summary of Safety and Effectiveness for the Lumina, Prosun, Luxura, Onyx, and Jade sunlamp tanning bed product lines.
Submitter Information:
ProSun International LLC 2442 23rd Street North Saint Petersburg, Florida 33713-4018 Tel - 727-825-0400 Fax - 727-825-0700
Official Contact:
Jennifer C. Henkemans, Chief Operating Officer 2442 23rd Street North Saint Petersburg, Florida 33713-4018 Tel - 727-825-0400 Fax – 727-825-0700 jenniferh@prosun.com
Regulatory Consultant: N/A
Date Prepared: May 31, 2018
1.5.1 - PROPOSED DEVICE IDENTIFICATION
All proposed devices have originally been listed as Class I devices (510(k) exempt sunlamp product) and legally offered for sale before September 2, 2014. In accordance with the final order (Federal Register, Volume 79, Number 5) these proposed devices are used as predicate devices for substantial equivalence purposes.
Device Trade Name: ProSun sunlamp products Common Name: Prosun sunlamp products Classification Name: Booth, Sun Tan (21 CFR 878.4635, Product Code LEI) Classification Panel: General & Plastic Surgery Device Class: Class II
4
The following table presents the proposed ProSun sunlamp products. The Jade, Onyx, RelaxSun and ProSun sunlamp products represent technically and fundamentally the same basic products which do not alter any technical specifications or aspects of the devices.
| Current Model | Historical Model | Marketing Name | Brand and Type Name |
|---|---|---|---|
| 12 | 24 Series | 12 V | ProSun Canopy Tanner |
| 24 | 24 Series | RelaxSun 24 | RelaxSun 24 |
| 24J | 24 Series | JADE 24 | ProSun Jade 24 |
| 28 | 28 Series | ONYX 28 | ProSun ONYX 28 |
| 32J | 32 Series | JADE 32 | ProSun Jade 32 |
| 32 | 32 Series | ONYX 32 | ProSun ONYX 32 |
| 32/1 | 32 Series | ONYX 32 SLi | ProSun ONYX 32 SLi Intensive (110) |
| 32/1-P | 32 Series | ONYX 32 SLi | ProSun ONYX 32 SLi Intensive (160) |
| 36V | 36 Series V | V1 | ProSun V1 |
| 42V3 | 42 Series V | V3 | ProSun V3 42 XLc High Intensive |
| Device Trade Name: | Luxura sunlamp products |
|---|---|
| Common Name: | Luxura sunlamp products |
| Classification Name: | Booth, Sun Tan (21 CFR 878.4635, Product Code LEJ) |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
The following table presents the Luxura sunlamp products. The Luxura sunlamp products represent technically and fundamentally the same basic products which do not alter any technical specifications or aspects of the devices.
| Current Model | Historical Model | Marketing Name | Brand and Type Name |
|---|---|---|---|
| 34X | 34 Series | X5 | Luxura 34 SLi Intensive |
| 36X | 36 Series | X3 (120) | Luxura 36 SLi High Intensive |
| 36X-P | 36 Series | X3 (180) | Luxura 36 SLi High Intensive |
| 38X | 38 Series | X5 | Luxura 38 SLi High Intensive |
| 42X | 42 Series | X7 | Luxura 42 SLi High Intensive |
| 42V6 | 42 Series V | V6 | Luxura 42 XL Ultra Intensive |
| 48V6 | 48 Series V | V6 | Luxura 48 XL Ultra Intensive |
| 48V8 | 48 Series V | V8 | Luxura 48 XL Ultra Intensive |
| 48V8-E | 48 Series V | V8 E | Luxura V8 48 E-Power |
| 52X/VEGAZ | 52 Series | X10/VEGAZ | Luxura X10/VEGAZ |
5
1.5.2 - DEVICE CLASSIFICATION
Classification Name: Booth, Sun Tan (21 CFR 878.4635, Product Code LEI) Classification Panel: General & Plastic Surgery Device Class: Class II
1.5.3 - DEVICE DESCRIPTION
The primary technical components of sunlamp products are whole body tanning devices consisting of a mechanical frame with Ultraviolet (UV) lamps providing an artificial source of UV radiation. The UV light is intended for irradiation of the human body to induce skin tanning. The user of the proposed devices device either lies in the horizontal tanning bed or stands in the vertical tanning booth.
Skin tanning varies with skin type and as the UV sources intensities with characteristic UV-A and UV-B proportions result in cosmetic tanning of the human skin.
The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but fades more rapidly. The UV-B radiation is primarily responsible for more longterm tanning results.
1.5.4 - INTENDED USE
Tanning Bed Systems are intended to provide tanning of the human skin.
1.5.5 - PREDICATE & SUBSTANTIAL EQUIVALENCE DEVICES
All proposed devices have originally been listed as Class I devices (510(k) exempt sunlamp product) and legally offered for sale before September 2, 2014. In accordance with the final order (Federal Register, Volume 79, Number 5) these proposed devices are used as predicate devices for substantial equivalence purposes.
1.5.6 - COMPARISON TO PREDICATE & SUBSTANTIAL EQUIVALENCE DEVICES
The following table represents the technological characteristics and parameters of the proposed devices.
6
ProSun International, LLC 2442 23rd Street North Saint Petersburg, Florida 33713-4018
| New
Model
Number | Legacy
Model
Number | Marketing
Name | Brand and Type
Name | Canopy
Lamps | Lamp
Watts | Bench
Lamps | Lamp
Watts | Facial
Lamps | Lamp
Watts | Max
Exposure
Min. |
|------------------------|---------------------------|-------------------|------------------------------------|-----------------|---------------|----------------|---------------|-----------------|---------------|-------------------------|
| 12 | 24 Series | 12V | Canopy Tanner | 12 | 100 | n/a | 0 | n/a | 0 | 20 |
| 24J | | | | | | | | | | 20 |
| | 24 Series | JADE 24 | Jade 24 | 12 | 100 | 12 | 100 | n/a | 0 | |
| 24 | | RelaxSun | | | | | | | | 20 |
| | 24 Series | 24 | RelaxSun 24 | 12 | 100 | 12 | 100 | n/a | 0 | |
| 28 | 28 Series | ONYX 28 | Onyx 28 | 14 | 110 | 14 | 100 | n/a | 0 | 20 |
| 32/1-P | | | Onyx 32 Sli | | | | | | | 12 |
| | 32 Series | ONYX 32 Sli | Intensive | 12 | 160 | 14 | 100 | 1 | 400 | |
| | | | | 5 | 140 | | | | | |
| 32/1 | 32 Series | ONYX 32 Sli | Onyx 32 Sli | 12 | 110 | 14 | 100 | 1 | 400 | 15 |
| | | | | 5 | 80 | | | | | |
| 32 | 32 Series | ONYX 32 | Onyx 32 | 18 | 110 | 14 | 100 | n/a | 0 | 20 |
| 36V | 36 Series | | | | | | | | | 12 |
| | V | V1 | Prosun V1 | 36 | 110 | n/a | 0 | n/a | 0 | |
| 36X-P | | | Luxura 36 Sli High
Intensive | | | | | | | 12 |
| | 36 Series | X3 | | 20 | 160 | 16 | 180 | 3 | 400 | |
| 36X | | | Luxura X3 36 Sli
Intensive | | | | | | | 15 |
| | 36 Series | X3 | | 20 | 160 | 16 | 120 | 3 | 400 | |
| 38X | | | Luxura 38 Sli High
Intensive | | | | | | | 12 |
| | 38 Series | X5 | | 22 | 160 | 16 | 180 | 3 | 400 | |
| 42X | | | Luxura 42 Sli High
Intensive | | | | | | | 12 |
| | 42 Series | X7 | | 24 | 160 | 18 | 180 | 4 | 400 | |
| 42V3 | 42 Series | | Prosun V3 42 XLc
High Intensive | | | | | | | 10 |
| | V | V3 | | 42 | 160 | n/a | 0 | n/a | 0 | |
| 42V6 | 42 Series | | Luxura 42 XL
Ultra Intensive | | | | | | | 10 |
| | V | V6 | | 42 | 180 | n/a | 0 | n/a | 0 | |
| 48V6 | 48 Series | | Luxura 48 V6 XL
Ultra Intensive | | | | | | | 9 |
| | V | V6 | | 48 | 200 | n/a | 0 | n/a | 0 | |
| 48V8-E | 48 Series | | Luxura V8 48 E-
Power | | | | | | | 9 |
| | V | V8-E | | 48 | 200 | n/a | 0 | n/a | 0 | |
| 48V8 | 48 Series | | Luxura 48 XL
Ultra Intensive | | | | | | | 9 |
| | V | V8 | | 48 | 200 | n/a | 0 | n/a | 0 | |
| 52X | | | Luxura 52 Sli High
Intensive | | | | | | | 10 |
| | 52 Series | X10/VEGAZ | | 30 | 160 | 22 | 180 | 4 | 520 | |
1.5.6 – COMPARISON TO PREDICATE & SUBSTANTIAL EQUIVALENCE DEVICES
The previous and following table represents the technological characteristics and parameters of the identified predicate devices and proposed devices. The Proposed Devices and the Predicate
7
Devices are the same devices which are unchanged and are totally equal. Therefore the list of Proposed Devices equals the Predicate Devices which are listed as follows.
| New
Model
Number | Model
Number | Marketing
Name | Brand and Type
Name | Substantially
Equivalent
Model | FDA 3630
Accession # | Old FDA
3630
Accession # | FDA
510(k)
K# |
|------------------------|-----------------|-------------------|------------------------------------|--------------------------------------|-------------------------|--------------------------------|---------------------|
| 12 | 24 Series | 12V | Canopy Tanner | Prosun 12 /24 Series | 9520183-008 | 9212092-00 | K944015 |
| 24J | 24 Series | JADE 24 | Jade 24 | Prosun 24 Series | 9520183-008 | 9520183-04 | K944015 |
| 24 | 24 Series | RelaxSun 24 | RelaxSun 24 | Prosun 24 Series | 9520183-008 | 9520183-04 | K944015 |
| 28 | 28 Series | ΟΝΥΧ 28 | Onyx 28 | Prosun 28 Series | 9520183-009 | 9712092-02 | K944015 |
| 32/1-P | 32 Series | ΟΝΥΧ 32
Sli | Onyx 32 Sli
Intensive | Prosun 32 Series | 9520183-009 | 9712092-02 | K944015 |
| 32/1 | 32 Series | ΟΝΥΧ 32
Sli | Onyx 32 Sli | Prosun 32 Series | 9520183-009 | 9712092-02 | K944015 |
| 32 | 32 Serirs | ΟΝΥΧ 32 | Onyx 32 | Prosun 32 Series | 9520183-009 | 9712092-02 | K944015 |
| 36V | 36 Series | V1 | Prosun V1 | Prosun 36 Series | 9922525-001 | 9922527-00 | K944015 |
| 36X-P | 36 Series | X3 | Luxura 36 Sli
High Intensive | Prosun 36 Series | 9922525-001 | 9922527-00 | K944015 |
| 36X | 36 Series | X3 | Luxura X3 36 Sli
Intensive | Prosun 36 Series | 9922525-001 | 9922527-00 | K944015 |
| 38X | 38 Series | X5 | Luxura 38 Sli
High Intensive | Prosun 38 Series | 972092-008 | 972092-06 | K944015 |
| 42X | 42 Series | X7 | Luxura 42 Sli
High Intensive | Prosun 42 Series | 972092-008 | 972092-06 | K944015 |
| 42V3 | 42 Series | V3 | Prosun V3 42 XLc
High Intensive | Prosun 42 Series | 9922525-001 | 9922527-00 | K944015 |
| 42V6 | 42 Series
V | V6 | Luxura 42 XL
Ultra Intensive | Prosun 42 Series | 9922525-001 | 9922527-00 | K944015 |
| 48V6 | 48 Series
V | V6 | Luxura 48 XL
Ultra Intensive | Luxura 48 Series | 9922525-002 | 9922525-00 | K944015 |
| 48V8-E | 48 Series
V | V8 | Luxura V8 48 E-
Power | Luxura 48 Series | 9922525-002 | 9922525-00 | K944015 |
| 48V8 | 48 Series
V | V8 | Luxura 48 XL
Ultra Intensive | Luxura 48 Series | 9922525-002 | 9922525-00 | K944015 |
| 52X/VEGAZ | 52 Series | X10/VEGAZ | Luxura
X10/VEGAZ | Prosun 52 Series | 9922524-001 | 9922524 | K944015 |
8
1.5.7 - SUMMARY OF PERFORMED TESTS
The proposed devices have been non clinically tested in accordance with:
- . Biocompatibility and in accordance with DIN EN ISO 10993
- . Electrical and mechanical safety in accordance with IEC 60601-1 (IEC 60335-2-27 and UL 482)
- . EMC in accordance with IEC 60601-1-2 (CISPR 14-1 and 14-2)
- . Spectral emissions of all sunlamp products were measured. The test procedure for measuring the spectral emission is in accordance with IEC 6033-2-27 and 21 CFR 1002, 1010 — 1050).
- . Irradiance ratio limits of all proposed sunlamp products are in accordance with 21 CFR 1040.2(c)(1).
- . Software verification & validation testing according to FDA's "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices"
- . The maximum timer intervals and exposure schedules have been determined according to FDA's "Policy on maximum timer interval and exposure schedule for sunlamp products."
- . Performance Standards testing in accordance with 21 CFR 1040.20
1.5.8 — CONCLUSION
PROSUN INTERNATIONAL LLC believes that based on analysis of the technological characteristics based on non-clinical performance data and historical field experience based on the same indications for use PROSUN INTERNATIONAL LLC believes the ProSun, Lumina, Luxura, Onyx, and Jade sunlamp products are substantially equivalent to currently legally marketed predicate devices. All Special Controls for Class 2 EMDRM as defined by the FDA are fulfilled. These devices do not introduce new Indications For Use, they have the same technological characteristics and do not introduce any new issues of potential hazards, safety risks, effectiveness or usability.