Solar Tone Booth

No FDA recalls on record, checked 6 Oct 2026.

Full name

Solar Tone

510(k) Number

K802304 ↗

FDA Product Code

LEJ

Device Class

Class II

Regulation

21 CFR Part 878.4635

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Slendertone

  Class II

  FDA 510(k) K790120 Active Cleared 7 May 1979

• Bx-400 Jesse Jimbody

  Class II

  FDA 510(k) K813410 Active Cleared 8 Mar 1982

• Electronic Muscle Exercise Equipment (K841779)

  Class II

  FDA 510(k) K841779 Active Cleared 30 May 1984

• Bx-400

  Class II

  FDA 510(k) K842142 Active Cleared 25 Jun 1984

• Model P-8 Professional

  Not classified

  FDA 510(k) K811114 Active Cleared 23 Nov 1981

• Bx-400 Sport

  Class II

  FDA 510(k) K813443 Active Cleared 8 Mar 1982

See all devices from Bloomex International, Inc. →

• What is the Solar Tone Booth primarily used for in a clinical or professional setting?

  The Solar Tone Booth is designed for controlled artificial tanning in professional tanning salons or similar environments. It emits ultraviolet (UV) radiation to stimulate melanin production, helping users achieve a gradual tan without relying on natural sunlight exposure. It is classified as a Class II medical device under FDA regulations and is not intended for medical treatment but rather cosmetic purposes.

• Is the Solar Tone Booth intended for single-use or reusable applications, and what does this mean for maintenance?

  The Solar Tone Booth is explicitly supplied as a reusable device, meaning it is not meant for single-use. This requires proper maintenance and cleaning protocols to ensure safe and effective operation over time, as outlined by the manufacturer’s guidelines. Reusability also means it must be handled and stored carefully to prevent contamination or damage.

• What storage and handling considerations should be taken for the Solar Tone Booth?

  The Solar Tone Booth should be stored and handled according to the manufacturer’s instructions to maintain its functionality and safety. While no specific storage conditions are detailed, typical UV-emitting devices require protection from environmental factors like moisture, extreme temperatures, and physical damage. Regular inspections and adherence to maintenance schedules will help ensure consistent performance and longevity.

• How is the regulatory status of the Solar Tone Booth determined, and what does this mean for buyers?

  The Solar Tone Booth holds FDA 510(k) clearance (K802304) and is classified under product code LEJ, which categorizes it as a sun-tanning booth. This clearance indicates it has been deemed substantially equivalent to a legally marketed device already on the market, meaning it meets FDA safety and effectiveness requirements for its intended use. Buyers can rely on this status to confirm the device complies with regulatory standards for artificial tanning equipment.