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510(k) Data Aggregation
K Number
K152405Device Name
IBL 5000 Tanning Booth
Manufacturer
IBL ACQUISITIONS LLC
Date Cleared
2016-09-01
(373 days)
Product Code
LEJ
Regulation Number
878.4635Why did this record match?
Applicant Name (Manufacturer) :
IBL ACQUISITIONS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to be used for the tanning of Human Skin.
Device Description
The IBL 5000 tanning booth is available in two configurations, a 200W configuration that utilizes 79 inch fluorescent UV lamps and a 160W configuration that utilizes 71 inch fluorescent UV lamps. Each configuration consists of a metal structure with 50 lamps vertically arranged in a manner that surrounds the tanner so as to provide a consistent all around tan. The user stands in the center of the booth. Double doors allow entry and exit from the booth. The lamps are powered by inductive (choke) type ballasts. The duration of exposure is controlled by a user settable electronic timer. The session time can be set to any value called for on the recommended exposure schedule. Session time cannot be set longer than the maximum recommended exposure schedule time. A backup timer is provided that ensures the booth's lamps cannot operate longer than the maximum recommended exposure. A stop switch is provided within the tanning area to immediately turn off the UV lamps if needed.
The dosage of UV irradiation is within allowable limits set by the FDA performance standard 21 CFR 1040.20 and FDA Guidance letter dated August 21st 1986 titled Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products.
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