(340 days)
Not Found
No
The summary describes a standard UV tanning booth and makes no mention of AI or ML technology.
No.
The device is described as an over-the-counter tanning device for cosmetic purposes (skin tanning). It does not claim to treat or diagnose any medical condition or disease.
No
Explanation: The device is described as an over-the-counter tanning device intended for tanning human skin, not for diagnosing any medical conditions.
No
The device description explicitly states it consists of a "mechanical structure equipped with artificial light sources," indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The i8 tanning booth directly interacts with the human body (skin) by emitting UV light for tanning. It does not perform any tests on samples taken from the body.
- Intended Use: The intended use is for "tanning of the human skin," which is a cosmetic or aesthetic purpose, not a diagnostic one.
- Device Description: The description clearly states it's a "tanning device" that uses UV light to "induce skin tanning."
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
Therefore, based on the provided information, the i8 tanning booth is a tanning device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The i8 tanning booth is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum for the tanning of the human skin of an adult person.
Product codes
LEJ
Device Description
Ultrasun International B.V. i8 Sun Tanning Booth is a tanning device consisting of a mechanical structure equipped with artificial light sources using ultraviolet light technology, which produces ultraviolet radiation within the UVA and UVB ranges. The UV light is intended to induce skin tanning. The user stands within the unit.
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
adult person
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
- Electrical and mechanical safety testing in accordance with IEC 60601-1:2005 + A1:2012
- Electromagnetic compatibility testing in compliance with IEC 60601-1-2:2007
- Software development per IUC 62304:2016
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.
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.
December 10, 2021
Ultrasun International B.V. % Shepard Bentley President & Principal Consultant Bentley Biomedical Consulting, LLC 28241 Crown Valley Parkway, Suite 510(k) Laguna Niguel, California 92677
Re: K210004
Trade/Device Name: i8 Tanning Booth Regulation Number: 21 CFR 878.4635 Regulation Name: Sunlamp Products And Ultraviolet Lamps Intended For Use In Sunlamp Products Regulatory Class: Class II Product Code: LEJ Dated: December 28, 2020 Received: January 4, 2021
Dear Shepard Bentley:
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/cfdocs/cfpmn/pmn.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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210004
Device Name i8 Tanning Booth
Indications for Use (Describe)
The i8 tanning booth is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum for the tanning of the human skin of an adult person.
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)
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510(k) SUMMARY
(according to 21 CFR §807.92)
1. GENERAL INFORMATION
| Submitter: | Ultrasun International B.V. |
|---|---|
| Granaatstraat 6 | |
| 7554 TR Hengelo | |
| The Netherlands | |
| Phone: +31 74 2912215 | |
| Official Correspondent: | Shepard G. Bentley, RAC |
| Bentley Biomedical Consulting, LLC | |
| 28241 Crown Valley Parkway, Suite 510(k) | |
| Laguna Niguel, CA 92677 | |
| Phone: (949) 374 – 9187 | |
| Email: sbentley@bentleybiomed.com | |
| Preparation Date: | December 6, 2021 |
| 2. SUBJECT DEVICE | |
| Device Name: | i8 Tanning Booth |
| Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ (21 CFR §878.4635) |
| Classification Panel: | General Surgery Devices (DHT4A) |
| Device Class: | Class II - Special Controls |
| 3. PREDICATE DEVICE |
Device Name:
IBL 5000 Tanning Booth
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| Classification Name: | Booth, Sun Tan |
|---|---|
| ---------------------- | ---------------- |
LEJ (21 CFR §878.4635) Product Code:
Classification Panel: General Surgery Devices (DHT4A)
Device Class: Class II - Special Controls
510(k) Number: K152405
4. DEVICE DESCRIPTION
Ultrasun International B.V. i8 Sun Tanning Booth is a tanning device consisting of a mechanical structure equipped with artificial light sources using ultraviolet light technology, which produces ultraviolet radiation within the UVA and UVB ranges. The UV light is intended to induce skin tanning. The user stands within the unit.
5. INDICATIONS FOR USE
The i8 tanning booth is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum for the tanning of the human skin of an adult person.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Subject Device | Predicate Device | Evaluation | |
|---|---|---|---|
| Device Trade Name | i8 | IBL 5000 | - |
| Number of Lamps | 48 x +200W | 50 x +200W | similar |
| Watts (Max Unit Power) | 9600 Watts | 10,000 Watts | similar |
| Maximum Exposure Time | 12 minutes / session | 12 minutes / session | same |
7. PERFORMANCE DATA
- Electrical and mechanical safety testing in accordance with IEC 60601-1:2005 + A1:2012 ●
- Electromagnetic compatibility testing in compliance with IEC 60601-1-2:2007
- Software development per IUC 62304:2016
8. CONCLUSION
Based on an analysis of the technological characteristics, non-clinical performance data, and indication for use, Ultrasun International B.V. believes that the subject device is substantially equivalent to the legally marketed predicate device, and does not raise any new issues of safety and effectiveness.