Solius bets FDA's new OTC UVB category sells home sunlight at $2,995

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.

That UVB's vitamin-D benefits could be dosed safely at home, and a brand-new FDA over-the-counter category would turn clinic-only phototherapy into a consumer market.

Solius closed a $23M Series A led by Lauder Partners in June 2026, announced alongside the Solius Pro launch.

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.

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.

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.

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.

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.

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.