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FDA 510(k)

uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS

K-Number: K152364 · 2016-04-14

ApplicantPc Marketing, Inc.
Decision Date2016-04-14
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS is a medical device manufactured by Pc Marketing, Inc.. It received FDA 510(k) clearance on 2016-04-14 under approval number K152364. 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 uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS?

uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS is a medical device that received FDA 510(k) clearance on 2016-04-14. It is manufactured by Pc Marketing, Inc.. The 510(k) number is K152364.

When was uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS approved by the FDA?

uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS received FDA 510(k) clearance on 2016-04-14, under approval number K152364.

What company makes uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS?

uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS is manufactured by Pc Marketing, Inc..

What is the FDA product code for uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS?

The FDA product code for uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS 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

View on FDA Database →

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

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