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510(k) Data Aggregation
(120 days)
Ultraviolet Sun Tanning Lamp
These devices are UV-B and UV-A lamps intended to provide ultraviolet radiation to tan the skin.
These UV Tanning lamps are medium pressure halide lamps with a quartz glass bulb, filled with metal halide, mercury and argon gas, equipped with 2 electrodes and a socket to provide ultraviolet radiation to induce skin tanning at any part of the living human body.
The provided text describes a 510(k) premarket notification for an "Ultraviolet Sun Tanning Lamp" and focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria through a study. Therefore, much of the requested information regarding acceptance criteria, study details, human readers, and ground truth is not present in this document.
However, I can extract the information that is available and clarify what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Requirements) | Reported Device Performance |
|---|---|
| Requirements of 21 CFR 878.4635 | Fulfilled |
| Performance Standard 21 CFR 1040.20 | Fulfilled |
| Irradiance values per nanometer (Watt/cm²/nm) over wavelength range of 200 to 400 nm | Reported in "product reports" |
| Irradiance ratios ( |
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