Decision Date2018-06-22
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
FIJI SUN FLUORESCENT TANNING UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Kdb Inc. (Dba) Sperti Sunlamp. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K151721. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FIJI SUN FLUORESCENT TANNING UNIT?
FIJI SUN FLUORESCENT TANNING UNIT is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is Kdb Inc. (Dba) Sperti Sunlamp. The 510(k) number is K151721.
When did FIJI SUN FLUORESCENT TANNING UNIT receive FDA 510(k) clearance?
FIJI SUN FLUORESCENT TANNING UNIT received FDA 510(k) clearance on 2018-06-22, under 510(k) number K151721.
Who is the listed applicant for FIJI SUN FLUORESCENT TANNING UNIT?
The FDA 510(k) record lists Kdb Inc. (Dba) Sperti Sunlamp as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FIJI SUN FLUORESCENT TANNING UNIT?
The FDA product code for FIJI SUN FLUORESCENT TANNING UNIT is LEJ.
Related Devices (Code: LEJ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.