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FDA 510(k)

Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy

K-Number: K152423 · 2016-05-20

ApplicantSunfire Industries, Inc.
Decision Date2016-05-20
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy is a medical device manufactured by Sunfire Industries, Inc.. It received FDA 510(k) clearance on 2016-05-20 under approval number K152423. 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 Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy?

Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy is a medical device that received FDA 510(k) clearance on 2016-05-20. It is manufactured by Sunfire Industries, Inc.. The 510(k) number is K152423.

When was Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy approved by the FDA?

Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy received FDA 510(k) clearance on 2016-05-20, under approval number K152423.

What company makes Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy?

Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy is manufactured by Sunfire Industries, Inc..

What is the FDA product code for Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy?

The FDA product code for Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy is LEJ.

Related Devices (Code: LEJ)

K151962KBL Sunlamp Products (= Device Bundling name)Kbl AG K152405IBL 5000 Tanning BoothIbl Acquisitions, LLC 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. K152364uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUSPc Marketing, 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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