Sun Beds

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K851255 ↗

FDA Product Code

FTC

Device Class

Class II

Regulation

21 CFR Part 878.4630

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Silgmann Solarium S-Type 1218 Combo

  Class II

  FDA 510(k) K840137 Active Cleared 23 Apr 1984

• Facial/Upper Body Unit

  Class II

  FDA 510(k) K851859 Active Cleared 14 May 1985

• Semi-Oval Modular Suntanning Booth

  Class II

  FDA 510(k) K802756 Active Cleared 22 Jan 1981

• Fold Away Hut

  Class II

  FDA 510(k) K851858 Active Cleared 14 May 1985

• Suntanning Home Unit

  Class II

  FDA 510(k) K812579 Active Cleared 8 Oct 1981

• Are Sun Beds intended for use in home settings, and if so, what supervision or training is required?

  Yes, Sun Beds are designed for use in both clinical and home settings. Since they are reusable and emit ultraviolet radiation for therapeutic or cosmetic skin treatment, their use in a home setting requires professional supervision or clear patient instruction to ensure safe and effective operation. Proper training on device operation, maintenance, and UV exposure protocols is essential to avoid risks like skin burns or overexposure.

• How do I determine which specific model of Sun Bed I need, given the multiple registration numbers listed?

  Each registration number corresponds to a specific variant or model of the Sun Bed, but they all adhere to the same regulatory framework and design intent. To determine the correct model for your needs, consult the manufacturer’s documentation or contact Tannhut directly. The registration numbers may reflect differences in specifications like UV output, bed size, or control features, so matching your clinical or patient requirements with the appropriate model is key.

• Do Sun Beds require sterilization, and what maintenance steps should I follow to keep them safe for use?

  Sun Beds are not sterile and are designed for reusable use. To maintain safety and effectiveness, they require regular cleaning and calibration. Proper maintenance includes disinfecting surfaces, ensuring UV output remains accurate, and following the manufacturer’s guidelines for upkeep. Since they emit UV radiation, maintenance should also include checking for any wear or damage that could compromise performance or patient safety.

• What regulatory pathway was used to clear Sun Beds for commercial distribution, and when was this decision made?

  Sun Beds were cleared for commercial distribution in the United States through the FDA’s Traditional 510(k) pathway, which demonstrates they are substantially equivalent to a legally marketed device. The decision was made on April 18, 1985, under the classification of Class II medical devices (regulation number 878.4630). This pathway ensures the device meets safety and effectiveness standards for controlled UV exposure in dermatological treatments.

• Are Sun Beds suitable for treating conditions like psoriasis or vitiligo, and how does the UV exposure work?

  Yes, Sun Beds are specifically designed to emit controlled ultraviolet (UV) radiation for therapeutic or cosmetic skin treatment, including conditions like psoriasis and vitiligo. The UV exposure helps modulate the immune response in the skin, reducing inflammation and promoting healing. However, their use must be supervised or guided by a professional to ensure proper dosing and avoid adverse effects like sunburn or long-term skin damage.