FDA 510(k) Application Details - K181308

Device Classification Name Laser, Comb, Hair

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510(K) Number K181308
Device Name Laser, Comb, Hair
Applicant Super Grow Lasers
1903 Commonwealth Street #16
Houston, TX 77006 US
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Contact Jeffrey Stanifer
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 05/17/2018
Decision Date 08/15/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K181308


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