The archive · Health & Care · Strategic decision · 2025–2026
Solius bets FDA's new OTC UVB category sells home sunlight at $2,995
The FDA created a product code so Solius Pro, a home UVB panel, could be sold without a prescription; Solius raised $23M and took 1,000+ pre-orders.
Solius Labs
What the business is
Solius Labs sells Solius Pro, a wall-mounted panel with 132 UVB LEDs whose app scans skin pigmentation and personalizes a weekly dose of under five minutes, cleared by the FDA to stimulate vitamin D production in adults 22 and older.
Starting capital：Solius closed a $23M Series A led by Lauder Partners in June 2026, announced alongside the Solius Pro launch.
How it started
The bet started with a measurement problem: UVB light drives vitamin D production and other biological processes, but sunlight is nearly impossible to dose safely — factors like season, latitude, skin tone and sun sensitivity make a consistent beneficial dose impractical, while phototherapy with UVB existed only in medical settings. Solius designed a home panel and algorithm to change that, then faced the harder question: no regulatory path existed for selling UVB therapy over the counter.
What happened
The FDA answered by creating a new product code for the device. Solius submitted the Solius Pro UVB Light Panel as a traditional 510(k) on 2025-09-16 and received a substantially-equivalent decision on 2026-01-16, clearing it as a Class II medical device for over-the-counter marketing — stimulating vitamin D production in people 22 and older — under the new SGZ code. In an August 2025 randomized controlled trial funded by Solius, 69 participants over 21 weeks saw serum vitamin D rise by about 10 ng/mL on average with no skin damage or tanning. On 2026-06-16 the company launched Solius Pro at $2,995 with a $100-per-year membership, backed by a $23M Series A led by Lauder Partners and more than 1,000 pre-orders.
How it ended up
Solius Pro went on sale in the US on 2026-06-16 as the first FDA-cleared over-the-counter UVB therapy device, with shipping starting in July 2026 — the company turned a regulatory category that did not exist into its launch moat.
Background
Solius Labs sells Solius Pro, a home light panel whose 132 UVB LEDs deliver a personalized weekly dose of under five minutes, guided by an app that scans skin pigmentation and calculates exposure from an algorithm built on about 10,000 skin samples. Its founding bet was that UVB's biological benefits — most simply vitamin D production — could be delivered safely at home, something sunlight cannot reliably do and clinic phototherapy never made consumer-grade.
The obstacle was regulatory: UVB therapy had no over-the-counter path in the US. Solius submitted a traditional 510(k) on 2025-09-16, and on 2026-01-16 the FDA found the device substantially equivalent, clearing it as a Class II medical device for over-the-counter sale under a newly created product code, SGZ, to stimulate vitamin D production in adults 22 and older. In an August 2025 randomized controlled trial Solius funded, 69 participants saw serum vitamin D rise by about 10 ng/mL on average over 21 weeks without skin damage.
On 2026-06-16 Solius launched Solius Pro at $2,995 with a $100-per-year membership, supported by a $23M Series A led by Lauder Partners and more than 1,000 pre-orders before July shipping. CNET ran the launch as the arrival of a brand-new category — over-the-counter phototherapy — with the company arguing the device delivers 12 times the healthy UVB of the sun at 99% less total UV risk.
What has to be true
- Sunlight is free but undosable, which is exactly the gap a regulated device can fill: consistent UVB dosing is a clinical benefit that nature cannot deliver safely.
- FDA's new product code removed the prescription barrier and the clinic visit, turning phototherapy from a reimbursed medical procedure into a consumer purchase.
- Personalization made the safety case: a skin scan and algorithm set each dose, which is how the company convinced regulators that untrained home users could operate UVB therapy safely.
- The launch sequencing — pre-orders before shipping, a $23M Series A, and mainstream coverage on day one — showed buyers and press treat a first-in-category FDA clearance as proof.
What can be applied
When a product needs a category that does not exist, getting the regulator to create it is the real launch: the new FDA product code was Solius's moat, not its paperwork.
Aftermath
As of 2026-06-16 Solius Pro is on sale in the US, shipping from July 2026, and Solius holds the over-the-counter phototherapy category it helped create. The device is cleared only for stimulating vitamin D production in adults 22 and older and is not recommended for people with photosensitivity disorders or a history of skin cancer, CNET noted. Solius says research continues on UVB-driven effects such as bone health, cardiovascular function and the gut microbiome, and it is exploring dermatologic applications with the National Psoriasis Foundation.
Sources
- FDA Clears Solius Pro, the First Over-the-Counter Home UVB Panel for Vitamin D
- Solius Pro Cleared by FDA and Launched as an Over-the-Counter At-Home UVB Device
- 510(k) Premarket Notification K252960 — Solius Pro UVB Light Panel
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