North Andover, MA — Sun Capsule has become one of the first domestic manufacturers of tanning equipment to receive a 510(k) clearance notice from the United States Food and Drug Administration (FDA).
A 510(k) notice clears a product for sale in the U.S., classifying a product as safe for customer use. “The FDA’s clearance shows Sun Capsule’s dedication to our customers’ and clients’ safety,” says Thomas Holland, President of Sun Capsule.
“Our product is subjected to the same demanding standards by the FDA as any Class II medical device,” continued Holland. “Our product meets and exceeds those requirements. We are committed to providing the best-performing and safest equipment on the market, and we’ve proven exactly that with this news.”
The FDA’s notice arrives at the start of what’s poised to be a record-breaking year for the Massachusetts-based company. Through their progressive financing plans for salon owners and aggressive pursuit of manufacturing quality, Sun Capsule has become the undisputed leader in the vertical tanning booth industry.
Thomas Holland says the FDA clearance is only the most recent of important milestones for the company: “We produced the first vertical tanning booth, had the first seven-minute tan. Even with thirty-five years in the industry, Sun Capsule is still on the cutting edge.”
Holland added that he owes Sun Capsule’s success to his customers, saying that without their support the company wouldn’t exist as it’s known today.