(122 days)
SOLIUS PRO is an over-the-counter (OTC) light panel intended to stimulate production of Vitamin D in people 22 years and older.
The SOLIUS PRO is a portable, over-the-counter (OTC) photobiomodulation light panel designed for home or facility use. The device stimulates vitamin D production through controlled exposure of a targeted ultraviolet B (UVB) spectrum ranging from 280-315 nm. Specialized UVB LEDs deliver a controlled UVB emission aligned with the action spectrum for vitamin D synthesis while incorporating multiple technological and software safety features.
The SOLIUS PRO provides a uniform light output across an area of exposed skin on the torso to optimize vitamin D production while minimizing unnecessary exposure to the face and eyes. A height-adjustable hanging system positions the panel at shoulder level, and an integrated distance sensor ensures the user maintains the optimal distance for both safety and effectiveness.
Before the first therapy session, the Personalized Dosing System uses a built-in optical sensor to quantifiably measure the Individual Typology Angle degree of the user's skin and a user response to a skin history question. The system calculates a personalized dose below 1 Minimal Erythema Dose (MED) that is delivered for a precisely controlled exposure time to stimulate vitamin D production and mitigate the risk of erythema.
Therapy sessions are initiated and monitored through a mobile application. The mobile application enforces the use of the provided protective eyewear by performing a facial scan before a session can begin. Once therapy begins, the system provides real-time visual and audio feedback from the distance sensor to assist user positioning. The mobile application records dosing information and user feedback and manages session scheduling and dose adjustments to ensure safe operation.
N/A
FDA 510(k) Clearance Letter - SOLIUS PRO UVB Light Panel
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.0 8 . 0 2
Silver Spring, MD 20993
www.fda.gov
January 16, 2026
Solius Labs, Inc.
℅ Shepard Bentley
Regulatory Consultant
Bentley Biomedical Consulting, LLC
28241 Crown Valley Parkway
Suite 510(k)
Laguna Niguel, California 92677
Re: K252960
Trade/Device Name: SOLIUS PRO UVB Light Panel
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: SGZ
Dated: September 15, 2025
Received: September 16, 2025
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 (the 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 available 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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K252960 - Shepard Bentley Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K252960 - Shepard Bentley Page 3
assistance/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,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2026.01.16 15:33:00 -05'00'
Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K252960
Device Name
SOLIUS PRO UVB Light Panel
Indications for Use (Describe)
SOLIUS PRO is an over-the-counter (OTC) light panel intended to stimulate production of Vitamin D in people 22 years and older.
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:
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SOLIUS Labs | 100 Ravine Lane, Suite 310 | Bainbridge Island | WA 98110 1
510(k) Summary – K252960
I. SUBMITTER
SOLIUS Labs, Inc.
100 Ravine Lane, Suite 310
Bainbridge Island, WA 98110
Ph: 202-487-3825
Contact Person: Shepard G. Bentley, RAC
Regulatory Consultant
Ph: 949-374-9187
Email: shepbentley@gmail.com
Date Prepared: January 16, 2026
II. DEVICE
Name of Device: SOLIUS PRO UVB Light Panel
Common or Usual Name: Ultraviolet Light Therapy Device
Classification Name: Ultraviolet lamp
Regulation Number: 21 CFR 878.4635
Regulatory Class: Class II
Product Code: SGZ
III. PREDICATE DEVICE
Name of Device: Sperti Sun Lamp Model P-164
Regulation Number: 21 CFR 878.4635
Regulatory Class: Class II (pre-amendment device, now regulated as Class II)
Product Code: RAB
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SOLIUS Labs | 100 Ravine Lane, Suite 310 | Bainbridge Island | WA 98110 2
IV. DEVICE DESCRIPTION
The SOLIUS PRO is a portable, over-the-counter (OTC) photobiomodulation light panel designed for home or facility use. The device stimulates vitamin D production through controlled exposure of a targeted ultraviolet B (UVB) spectrum ranging from 280-315 nm. Specialized UVB LEDs deliver a controlled UVB emission aligned with the action spectrum for vitamin D synthesis while incorporating multiple technological and software safety features.
The SOLIUS PRO provides a uniform light output across an area of exposed skin on the torso to optimize vitamin D production while minimizing unnecessary exposure to the face and eyes. A height-adjustable hanging system positions the panel at shoulder level, and an integrated distance sensor ensures the user maintains the optimal distance for both safety and effectiveness.
Before the first therapy session, the Personalized Dosing System uses a built-in optical sensor to quantifiably measure the Individual Typology Angle degree of the user's skin and a user response to a skin history question. The system calculates a personalized dose below 1 Minimal Erythema Dose (MED) that is delivered for a precisely controlled exposure time to stimulate vitamin D production and mitigate the risk of erythema.
Therapy sessions are initiated and monitored through a mobile application. The mobile application enforces the use of the provided protective eyewear by performing a facial scan before a session can begin. Once therapy begins, the system provides real-time visual and audio feedback from the distance sensor to assist user positioning. The mobile application records dosing information and user feedback and manages session scheduling and dose adjustments to ensure safe operation.
V. INDICATIONS FOR USE
SOLIUS PRO is an over-the-counter (OTC) light panel intended to stimulate production of vitamin D in people 22 years and older.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
SOLIUS PRO is substantially equivalent to the Sperti Sun Lamp Model P-164 predicate device. The detailed comparison between the Subject Device and the Predicate devices is provided in Table 1 below. SOLIUS PRO uses the same fundamental mode of action as the predicate (UVB stimulated vitamin D production) with additional safety controls to meet or exceed relevant safety standards.
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SOLIUS Labs | 100 Ravine Lane, Suite 310 | Bainbridge Island | WA 98110 3
Table 1. Comparison of the SOLIUS PRO light panel (subject device) and the Sperti (predicate device).
| SOLIUS PRO UVB Light Panel (subject device) | Sperti Sun Lamp Model P-164 (predicate device) | Substantial Equivalence Comparison | |
|---|---|---|---|
| Classification | Class II | Class II (Pre-amendment device) | N/A |
| 510(k) Number | K252960 | No 510(k) clearance | N/A |
| Intended Use | Intended to stimulate the production of vitamin D. | Activate sterols in the skin converting them to essential Vitamin D – known as the sunshine Vitamin. | Same |
| Indications for Use | SOLIUS PRO is an over-the-counter (OTC) light panel intended to stimulate production of vitamin D in people 22 years and older. | Activate sterols in the skin converting them to essential Vitamin D – known as the sunshine Vitamin. | Similar; differences in the indications statement do not impact the safety and effectiveness, nor substantial equivalence of the device. |
| OTC vs. Rx | OTC | OTC | Same |
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SOLIUS Labs | 100 Ravine Lane, Suite 310 | Bainbridge Island | WA 98110 4
| SOLIUS PRO UVB Light Panel (subject device) | Sperti Sun Lamp Model P-164 (predicate device) | Substantial Equivalence Comparison | |
|---|---|---|---|
| Light Source and Spectrum According to Nationally Recognized Testing Laboratory (NRTL) data. | Light Source: 132 precision UVB LEDs Spectral peak: single narrow peak at 294 nm in UVB range targeting the vitamin D action spectrum. Spectrum (% of total irradiance): 2.90% output @ ≥315 – 400 (UVA) 96.92% output @ ≥280 – <315 (UVB) 0.18% output @ 200 – <280 (UVC) | Light Source: 1 Mercury Arc Lamp Bulb Spectral peak: multiple peaks at 280, 296, 302, 312, 334, 366 nm. Spectrum (% of total irradiance): 62.62% output @ ≥315 – 400 (UVA) 36.51% output @ ≥280 – <315 (UVB) 0.88% output @ 200 – <280 (UVC) | Similar; both cover the 280-315 nm UVB spectrum. Similar; SOLIUS PRO is a targeted, narrow subset of the broader Sperti light spectrum. Different; SOLIUS PRO has one targeted light peak in the vitamin D action spectrum to maximize vitamin D production¹ and minimize total UVR exposure and risk of skin cancer.² |
| Treatment Area at Intended Distance | 20 in x 18 in | 30 in x 30 in | Similar |
¹ CIE 174:2006 Action spectrum for the production of previtamin D3 in human skin.
² Non-Melanoma Skin Cancer (NMSC) Action Spectrum according to ISO standard 28077:2006.
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SOLIUS Labs | 100 Ravine Lane, Suite 310 | Bainbridge Island | WA 98110 5
| SOLIUS PRO UVB Light Panel (subject device) | Sperti Sun Lamp Model P-164 (predicate device) | Substantial Equivalence Comparison | |
|---|---|---|---|
| Power Source | 100-240 V~, 50/60 Hz, 70 VA | 120 V~, 60 Hz, 400 W | Similar; SOLIUS PRO is more energy efficient and is designed to be compliant with United States and international power requirements. |
| Total UVR Irradiance According to Nationally Recognized Testing Laboratory (NRTL) data. | 242.53 uW/cm² | 365.40 uW/cm² | Different; performance testing demonstrates SOLIUS PRO delivers an equivalent vitamin D weighted dose with less total UVR exposure. |
| Output Uniformity According to Nationally Recognized Testing Laboratory (NRTL) data. | Maximum variation: 18.20% % of area with variation < -20%: 7% | Maximum variation: 125% % of area with variation < -20%: 39% | Different; performance testing demonstrates SOLIUS PRO provides tighter spatial uniformity which is intended to improve safety. |
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SOLIUS Labs | 100 Ravine Lane, Suite 310 | Bainbridge Island | WA 98110 6
| SOLIUS PRO UVB Light Panel (subject device) | Sperti Sun Lamp Model P-164 (predicate device) | Substantial Equivalence Comparison | |
|---|---|---|---|
| NRTL Certified Medical Safety Standards | SOLIUS PRO meets the following safety standards: • IEC 60601-1: Electrical Safety • IEC 60601-1-2: Electromagnetic Compatibility (EMC) • IEC 60601-1-6: Usability • IEC 60601-1-11: Home Healthcare Environment • IEC 60601-2-57: Medical Light Therapy • IEC 60601-2-83: Home Medical Light Therapy | None. | Different; Sperti was developed prior to the implementation of current safety standards. SOLIUS PRO meets current safety standards. |
| UV Exposure Safety Guidelines | SOLIUS PRO is below the Threshold Limit Values (TLV) for daily Ultraviolet Radiation (UV) exposure established by American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Values (TLV) 2024 for Ultraviolet Radiation (UV). | Sperti exceeds the Threshold Limit Values (TLV) for daily Ultraviolet Radiation (UV) exposure established by American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Values (TLV) 2024 for Ultraviolet Radiation (UV). | Different; Sperti was developed prior to the implementation of current UV exposure safety guidelines. SOLIUS PRO meets current UV exposure safety guidelines. |
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SOLIUS Labs | 100 Ravine Lane, Suite 310 | Bainbridge Island | WA 98110 7
| SOLIUS PRO UVB Light Panel (subject device) | Sperti Sun Lamp Model P-164 (predicate device) | Substantial Equivalence Comparison | |
|---|---|---|---|
| User Controls | Duration of 0 to 430 seconds (7.2 minutes), digital timer software control with redundancy. User creates profile in SOLIUS mobile app, completes user onboarding in app, and completes skin assessment to determine first dose. App displays therapy timer to user during therapy. After each dose, user must answer skin response question which is recorded and used to adjust dosing. | Duration of 0 to 10 minutes controlled with a manual timer, and label advises to "let your skin guide you" to adjust dose. User sets a manual timer (with hashmarks for 2, 4, 6, and 8 minutes) to turn on the lamp. First dose, titration, and ongoing therapies are based on label instructions and user experience. | Similar; additional safety controls. |
| Distance Monitor & Control | Distance sensors dynamically monitor user position to ensure user is within intended distance from light panel during therapy. Visual warning in the mobile app and audible warnings from the light panel are provided to the user when they are outside of the intended distance (too close or too far) and therapy will shut off if user does not stay within the intended distance. | Label advises a ruler to ensure user is at the intended distance from the light during therapy. | Similar; additional safety controls. |
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SOLIUS Labs | 100 Ravine Lane, Suite 310 | Bainbridge Island | WA 98110 8
| SOLIUS PRO UVB Light Panel (subject device) | Sperti Sun Lamp Model P-164 (predicate device) | Substantial Equivalence Comparison | |
|---|---|---|---|
| First Dose | Software guides user through quantitative and repeatable skin measurement using a sensor and a response to a skin history question to determine a personalized dose duration below 1.0 minimal erythema dose (MED) on first therapy for all users. | Label advises all users that "initial exposure should not exceed 3 minutes." | Similar; both devices guide initial dose while SOLIUS PRO first dose is managed by safety controls validated by performance testing which demonstrates a reduced risk of erythema. |
| Titration | Optional titration of 20% per therapy (up or down) according to American Academy of Dermatology UVB titration guidelines.³ Software records user skin response after each session and automatically reduces dose if user reports skin irritation. | Label advises "Each day increase the exposure time no more than one minute." Example scenarios based on label recommendations: a) First dose of 1 minute, increase one minute to 2 minutes = 100% dose increase b) Dose of 5 minutes, increase one minute to 6 minutes = 20% dose increase | Similar; additional safety controls. |
³ Elmets CA, et. al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy. J Am Acad Dermatol. 2019 Sep;81(3):775-804. doi: 10.1016/j.jaad.2019.04.042. Epub 2019 Jul 25. Erratum in: J Am Acad Dermatol. 2020 Mar;82(3):780. doi: 10.1016/j.jaad.2019.11.024. PMID: 31351884.
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SOLIUS Labs | 100 Ravine Lane, Suite 310 | Bainbridge Island | WA 98110 9
| SOLIUS PRO UVB Light Panel (subject device) | Sperti Sun Lamp Model P-164 (predicate device) | Substantial Equivalence Comparison | |
|---|---|---|---|
| Frequency | Therapy calendar in the SOLIUS software User Profile tracks usage and locks out user to ensure at least 24-hour period between therapy sessions. This control ensures SOLIUS does not exceed daily exposure limit according to American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Values (TLV) 2024 for Ultraviolet Radiation (UV). | Label advises "Exposure should not be repeated more often than once daily." | Similar; with additional safety controls. |
| Eyewear Enforcement | Proper use of SOLIUS provided protective eyewear is confirmed by the mobile app facial scan prior to initiating a therapy session. | Label suggests wearing included protective eyewear, but it is not enforced. | Similar; with additional safety controls. |
| Emergency Stop | Accessible stop button for emergency system shutdown and pause button provided in mobile app. | User must turn the timer knob or unplug the device from the wall. | Different; Sperti development was prior to the implementation of current UV exposure safety guidelines. SOLIUS PRO meets current UV exposure safety guidelines. |
³ Elmets CA, et. al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy. J Am Acad Dermatol. 2019 Sep;81(3):775-804. doi: 10.1016/j.jaad.2019.04.042. Epub 2019 Jul 25. Erratum in: J Am Acad Dermatol. 2020 Mar;82(3):780. doi: 10.1016/j.jaad.2019.11.024. PMID: 31351884.
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SOLIUS Labs | 100 Ravine Lane, Suite 310 | Bainbridge Island | WA 98110 10
VII. PERFORMANCE DATA
The following performance data was provided in support of the substantial equivalence determination.
Software and wireless safety:
Due to the software component and wireless functionality of the device, SOLIUS was assessed according to and in compliance with the following standard:
• IEC 62304:2006 Medical device software – Software life cycle processes
• AAMI TIR57:2016 Principles for medical device security – Risk Management
Cleaning and reprocessing:
Cleaning validation was performed to evaluate the efficacy of the cleaning procedure for the device. Testing was conducted in compliance with:
• ANSI/AAMI ST98:2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
• AAMI TIR12:2020 Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers
• FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration Staff. March 17, 2015
Packaging validation:
The packaging for the device was tested for shipping vibration and drop; no performance loss was observed in accordance with the following standard:
• ISTA 3A 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
Electrical safety and electromagnetic compatibility (EMC):
Electrical safety and EMC testing were conducted on the SOLIUS PRO light panel. The system complies with:
• IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (Home healthcare environment)
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SOLIUS Labs | 100 Ravine Lane, Suite 310 | Bainbridge Island | WA 98110 11
• IEC 60601-1-2:2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
Performance testing:
Photobiologic safety testing following IEC 62471:2006 was conducted on the SOLIUS PRO light panel. The system complies with:
• IEC 60601-2-57:2023 Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
• IEC 60601-2-83:2019 Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment (Home light therapy environment)
Additional optical radiation testing at the intended treatment distance was conducted by independent test lab to ensure SOLIUS PRO light panel peak wavelength, spectral distribution, and uniformity meets the specified requirement. Testing also confirmed optical radiation output is equivalent or safer when compared to the predicate device.
• UV dose per session verified below ACGIH 2024 TLV for daily UV exposure. Only one session is allowed per day, enforced by the mobile app
• Optical output testing verified SOLIUS PRO peak wavelength is within 293 nm ± 2 nm
• Optical output testing verified SOLIUS PRO contains > 95% UVB (280-315 nm) content
• Optical output testing verified SOLIUS PRO output uniformity over the treatment area is within ± 20% when compared to the average. A decrease in output greater than 20% is only at the edge of the treatment area, and accounts for less than 20% of the treatment area.
Human factors:
Usability testing was conducted by Eurofins Clinical Research Laboratories using the SOLIUS PRO device, in compliance with:
• IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
• IEC 62366-1:2015 Application of usability engineering to medical devices.
• AAMI/ANSI/HE75:2009 Human factors engineering – design of medical devices.
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SOLIUS Labs | 100 Ravine Lane, Suite 310 | Bainbridge Island | WA 98110 12
Dosage validation:
SOLIUS was evaluated through human use assessment conducted by third-party organizations to confirm appropriate dose control and absence of unexpected adverse skin reactions when the device is used as intended.
- A clinical study was performed by Eurofins Clinical Research Laboratories to validate the effectiveness of the SOLIUS PRO to measure skin and administer a UVB light dose below 1 Minimal Erythema Dose (MED) with the following results:
• 27 users across Fitzpatrick skin types I–VI were tested.
• 96% of users received an initial SOLIUS dose below or at 1.0 MED.
• 100% of users received the initial SOLIUS dose without reporting erythema, edema, or other adverse skin reactions.
• No adverse events were observed.
VIII. CONCLUSIONS
SOLIUS PRO UVB Light Panel is substantially equivalent to the Sperti Sun Lamp Model P-164 intended use and fundamental scientific technology (UVB exposure to stimulate vitamin D production). Differences, including LED light source, dosing personalization, and safety controls, do not raise new questions of safety or effectiveness. Performance and usability testing demonstrate that SOLIUS PRO is substantially equivalent to the predicate.
§ 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.