(268 days)
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Not Found
No
The device description focuses on basic electrical and mechanical components (lamps, timers, structure) and safety features. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
No.
The stated Intended Use is for "tanning of Human Skin," which is a cosmetic purpose, not a therapeutic one. The device description and performance studies focus on safety and compliance with tanning bed regulations, not on treating a medical condition.
No
The device is intended for the tanning of human skin and its description and performance studies focus on UV exposure and safety, not on diagnosing medical conditions.
No
The device description clearly outlines a physical tanning bed with lamps, a metal structure, and timers, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the tanning of Human Skin." This is a cosmetic or therapeutic use, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The device description details a tanning bed that uses UV lamps to tan skin. It does not involve the analysis of any biological specimens.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
The device is clearly designed for direct interaction with the human body for a non-diagnostic purpose (tanning).
N/A
Intended Use / Indications for Use
The device is intended to be used for the tanning of Human Skin.
Product codes (comma separated list FDA assigned to the subject device)
LEJ
Device Description
The Sunfire series of tanning beds is available in four configurations; a 32 lamp configuration that contains sixteen 71 inch fluorescent UV lamps in its canopy section and sixteen 71 inch fluorescent UV lamps in its bench sections, a 24 lamp configuration that contains twelve 71 inch fluorescent UV lamps in its canopy section and twelve 71 inch fluorescent UV lamps in its bench sections, a 16 lamp configuration that contains eight 71 inch fluorescent UV lamps in its canopy section and eight 71 inch fluorescent UV lamps in its bench sections, and a 12 lamp canopy only configuration that contains twelve 71 inch fluorescent UV lamps. Each configuration consists of a metal structure with lamps horizontally arranged in a manner so that they are equidistant from the tanner. The user of the Sunfire 32, 24 and 16 units lies down on the bench section and pulls down the canopy section, which is counterweighted by gas springs so that it can pivot and remain at any angle. The user of the Sunfire 12R lies down on a cot or bed and positions the Sunfire 12R canopy over their body. The lamps are powered by electronic type ballasts. The duration of exposure is controlled by a user settable electronic timer or alternatively an electromechanical timer. The session time can be set to any value called for on the recommended exposure schedule. Session time cannot be set longer than the maximum recommended exposure schedule time. A backup timer is provided that ensures the bed's lamps cannot operate longer than the maximum recommended exposure. A stop switch or knob is provided to immediately turn off the UV lamps if needed.
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
Contraindicated for people under 18 years old.
Intended User / Care Setting
Home 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)
Performance Testing (non-Clinical): Results of the UV irradiance testing performed on all lamp configurations confirm that the dosage is within allowable limits set by the FDA performance standard 21 CFR 1040.20 and FDA Guidance letter dated August 21st 1986 titled Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products.
The following additional factors were tested and/or evaluated:
- Timer Software Validation and Verification
- Biocompatibility of surfaces in contact with the tanner.
- Electromagnetic compatibility and electrical safety.
- Temperature of contact surfaces and temperature of air within tanning booth during operation.
The results from these performance evaluations demonstrate the Sunfire 24, Sunfire 16 and Sunfire 12R tanning beds meet the acceptance criteria defined in the performance standard and perform comparably to the predicate device.
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.
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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).
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§ 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 shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human profile, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
Sunfire Industries Inc. % Mr. Greg Bender Managing Member Bender & Bender Project Management Services LLC 3678 Gould Dr. Carmel, Indiana 46033
Re: K152423
Trade/Device Name: Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12r Tanning Canopy Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet Lamp For Tanning Regulatory Class: Class II Product Code: LEJ Dated: April 14, 2016 Received: April 19, 2016
Dear Mr. Bender:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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" (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 -A
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
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Indications for Use
510(k) Number (if known) K152423
Device Name Sunfire 32, Sunfire 24, Sunfire 16, Sunfire 12R
Indications for Use (Describe) The device is intended to be used for the tanning of Human Skin.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 description: The image shows the logo for Sunfire, along with their address. The address is 4905 Highway 70 East, New Bern, NC 28562. The logo is in gray and features a flame above the word Sunfire. There is a black dot between the address and the city, state, and zip code.
1-800-817-5083 Fax # (888) 253-0994
●
510(k) Summary As required by 21 CFR 807.92(c)
| Device Name | Sunfire 32, Sunfire 24, Sunfire 16, Sunfire 12R | |
|---|---|---|
| Submitters | ||
| name/contact | ||
| details | Sunfire Industries Inc. | |
| 4905 Hwy 70 E. | ||
| New Bern, NC 28562 | Contact Details: | |
| Doug Tyler | ||
| President | ||
| Tel: 800-552-4446 | ||
| Fax: 888-253-0994 | ||
| Summary | ||
| Preparation Date | 31st July 2015 | |
| Device Name & | ||
| Classification | Trade Name: | |
| Common Name: | ||
| Classification Name: | ||
| Device Classification: | ||
| Product Code: | Sunfire 32, Sunfire 24, Sunfire 16, Sunfire 12 | |
| Tanning Bed | ||
| Ultraviolet lamp for tanning | ||
| Class II, 21 CFR 878.4635 | ||
| LEJ | ||
| Intended Use: | The device is intended to be used for the tanning of human skin. | |
| Device Description: | The Sunfire series of tanning beds is available in four configurations; | |
| a 32 lamp configuration that contains sixteen 71 inch fluorescent UV lamps in its canopy section | ||
| and sixteen 71 inch fluorescent UV lamps in its bench sections, | ||
| a 24 lamp configuration that contains twelve 71 inch fluorescent UV lamps in its canopy section | ||
| and twelve 71 inch fluorescent UV lamps in its bench sections, | ||
| a 16 lamp configuration that contains eight 71 inch fluorescent UV lamps in its canopy section | ||
| and eight 71 inch fluorescent UV lamps in its bench sections, | ||
| and a 12 lamp canopy only configuration that contains twelve 71 inch fluorescent UV lamps. | ||
| Each configuration consists of a metal structure with lamps horizontally arranged in a manner so | ||
| that they are equidistant from the tanner. The user of the Sunfire 32, 24 and 16 units lies down on | ||
| the bench section and pulls down the canopy section, which is counterweighted by gas springs s | ||
| that it can pivot and remain at any angle. The user of the Sunfire 12R lies down on a cot or bed | ||
| and positions the Sunfire 12R canopy over their body. The lamps are powered by electronic type | ||
| ballasts. The duration of exposure is controlled by a user settable electronic timer or alternatively | ||
| an electromechanical timer. The session time can be set to any value called for on the | ||
| recommended exposure schedule. Session time cannot be set longer than the maximum | ||
| recommended exposure schedule time. A backup timer is provided that ensures the bed's lamps | ||
| cannot operate longer than the maximum recommended exposure. A stop switch or knob is | ||
| provided to immediately turn off the UV lamps if needed | ||
| 4905 Highway 70 East | New Bern, NC 28562 | Fax # (888) 253-099- |
| The dosage of UV irradiation is within allowable limits set by the FDA performance standard 21 | ||
| CFR 1040.20 and FDA Guidance letter dated August 21st 1986 titled Policy on Maximum Timer | ||
| Interval and Exposure Schedule for Sunlamp Products. | ||
| Predicate Devices | Sunfire Industries Inc. Models Sunfire 32, Sunfire 24, Sunfire 16 and Sunfire 12R May 6, 2014 | |
| Per Federal Register Vol. 79, No 105 Monday, June 2, 2014 Page 31212 Section IV Premarket | ||
| Notification. (Docket No. FDA-2013-N-0461) "any 510(k)-exempt sunlamp product or UV lamp | ||
| intended for sale on or before September 2, 2014, can serve as predicates for substantial | ||
| equivalence purposes." | ||
| Therefore, the Sunfire 32, 24,16 and 12R series will serve as their own predicates as they were | ||
| on the market prior to September 2, 2014. The Initial Product Report for the Sunfire 24 and 16 | ||
| was given accession reference number 1410322-000. The Product Report for the Sunfire 32 and | ||
| 12R was given accession reference number 1410322-001. | ||
| Comparison of | ||
| Characteristics | The Sunfire 32, Sunfire 24, Sunfire 16 and Sunfire 12R are identical to the units described in the | |
| submitted product reports, (FDA accession# 1410322-000 and 1410322-001) except that; | ||
| the mechanical timer is now supplemented by a separate back-up timer to guard against failure of | ||
| the main timer, | ||
| the alternate electronic timer has a built-in back-up timer, | ||
| UV Irradiance testing was performed on all lamp configurations to establish the exposure | ||
| schedule per FDA Guidelines. (refer to performance testing below) The results of these tests | ||
| provide reasonable assurance that the proposed device has been designed and tested to assure | ||
| conformance to the requirements for its intended use and performs comparably to the existing | ||
| device. The Sunfire 32, Sunfire 24, Sunfire 16 and Sunfire 12R are considered substantially | ||
| equivalent to the same model name predicate devices. | ||
| Labeling, Device labeling and user manual contraindications and warnings for both configurations | ||
| are in compliance with the requirements of 21 CFR 1040.20 and have been updated to comply | ||
| with the recently updated regulation 21 CFR 878.4635. See Proposed Labeling section of this | ||
| submittal. | ||
| Performance | ||
| Testing (non- | ||
| Clinical) | Results of the UV irradiance testing performed on all lamp | |
| configurations confirm that the dosage is within allowable limits set | ||
| by the FDA performance standard 21 CFR 1040.20 and FDA Guidance letter dated August 21st | ||
| 1986 titled Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products. | ||
| The following additional factors were tested and/or evaluated. | ||
| - Timer Software Validation and Verification |
- Biocompatibility of surfaces in contact with the tanner.
- Electromagnetic compatibility and electrical safety.
- Temperature of contact surfaces and temperature of air within tanning booth during
operation. | | |
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Image /page/4/Picture/1 description: The image shows the logo for Sunfire. The logo is in gray and features a stylized flame above the "i" in "Sunfire." Below the logo is the text "4905 Highway 70 East" followed by a bullet point and then the text "New Bern."
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Image /page/5/Picture/1 description: The image shows the word "Sunfire" in a stylized font. The letters are gray and appear to be three-dimensional. Above the "i" in "Sunfire" is a small gray flame. A thin black line runs horizontally beneath the word.
. New Bern, NC 28562 4905 Highway 70 East Fax # (888) 253-0994 The results from these performance evaluations demonstrate the Sunfire 24, Sunfire 16 and Sunfire 12R tanning beds meet the acceptance criteria defined in the performance standard and perform comparably to the predicate device. User Training Sunfire will establish a training program to ensure that each purchaser of equipment intended for home use comprehends the information presented on the device's labeling. Home use tanning equipment sold by Sunfire will ship with its control system disabled, preventing the equipment's use until a training program is completed. The training program will cover the following topics at a minimum. 1. Use of the exposure schedule to correctly define skin type and choose the appropriate session time to avoid overexposure (sunburn). Repeated exposure and especially overexposure can lead to skin aging and skin cancer. 2. 3. Importance of wearing approved eyewear to avoid injury to eyes. Contraindicated for people under 18 years old. 4. 5. Contraindicated when skin lesions or open wounds are present. Should not be used by those with skin cancer or have a family history of skin cancer. 6. 7. Allow time between tanning sessions for a tan to develop before tanning aqain.