Alpha Solar System Tanning Bed

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K943656 ↗

FDA Product Code

LEJ

Device Class

Class II

Regulation

21 CFR Part 878.4635

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• What is the Alpha Solar System Tanning Bed primarily used for, and in what setting is it intended to operate?

  The Alpha Solar System Tanning Bed is designed for cosmetic tanning purposes, simulating solar radiation through controlled ultraviolet (UV) exposure. It is intended exclusively for use in professional tanning facilities, not for home or clinical medical treatment. The device falls under FDA classification 878.4635 as a Class II medical device, with regulatory oversight tied to general and plastic surgery applications (product code LEJ), though its use remains strictly cosmetic.

• Is the Alpha Solar System Tanning Bed single-use or reusable, and what does that mean for maintenance?

  The Alpha Solar System Tanning Bed is not single-use—it is supplied as a reusable system for professional tanning facilities. This means the booth and its components are designed for repeated use, but operators must follow manufacturer guidelines for cleaning, UV lamp replacement, and general maintenance to ensure safety and performance. No sterility specifications are indicated, as the device is not intended for medical or surgical use.

• How many different models or configurations of the Alpha Solar System Tanning Bed have been registered with the FDA?

  The Alpha Solar System Tanning Bed has been registered under multiple FEI numbers (1450790; 3015276821; etc.), totaling 19 distinct registrations in the FDA database. These likely represent variations in size, lamp configurations, or booth dimensions, though the core design remains consistent for controlled UV exposure in professional settings. The variations are tracked under the same product code (LEJ) and regulatory classification.

• What was the FDA’s reasoning for clearing this device, and how does that affect its regulatory status?

  The Alpha Solar System Tanning Bed was cleared via a 510(k) submission (K943656) with a Substantially Equivalent (SESE) determination, meaning the FDA found it to be substantially equivalent to a legally marketed device already on the market. This clearance was granted under the General, Plastic Surgery advisory committee (SU) and classified as a Class II device, requiring compliance with FDA regulations for UV-emitting tanning equipment. The clearance does not imply medical efficacy—only that it meets safety and performance standards for its intended cosmetic use.

• What storage or handling considerations should be noted for the Alpha Solar System Tanning Bed?

  While specific storage instructions aren’t detailed in the data, as a reusable UV-emitting device, the Alpha Solar System Tanning Bed should be stored in a dry, temperature-controlled environment to protect components like lamps and wiring from damage. Operators should also ensure proper ventilation and avoid exposure to extreme conditions (e.g., humidity or direct sunlight) that could degrade performance. Since it’s not sterile, cleaning protocols should prioritize hygiene without compromising the device’s structural integrity.