FDA 510(k)

FIJI SUN FLUORESCENT TANNING UNIT

K-Number: K151721 · 2018-06-22

Decision Date2018-06-22

Product CodeLEJ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

FIJI SUN FLUORESCENT TANNING UNIT is a medical device manufactured by Kdb Inc. (Dba) Sperti Sunlamp. It received FDA 510(k) clearance on 2018-06-22 under approval 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. It is manufactured by Kdb Inc. (Dba) Sperti Sunlamp. The 510(k) number is K151721.

When was FIJI SUN FLUORESCENT TANNING UNIT approved by the FDA?

FIJI SUN FLUORESCENT TANNING UNIT received FDA 510(k) clearance on 2018-06-22, under approval number K151721.

What company makes FIJI SUN FLUORESCENT TANNING UNIT?

FIJI SUN FLUORESCENT TANNING UNIT is manufactured by Kdb Inc. (Dba) Sperti Sunlamp.

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)

K151962KBL Sunlamp Products (= Device Bundling name)Kbl AG K152405IBL 5000 Tanning BoothIbl Acquisitions, LLC K152423Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning CanopySunfire Industries, Inc. K152452Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200Medtek Lighting Corp D/B/A Peacock Tanning K152336HEX tanning boothJ & B Products Ltd Dba Hex Tanning K152412T-32;T-40;T-44;T-52;T-72;TT-50Tanses Technologies, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.