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510(k) K132518

NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE by Wellquest Intl., Inc. — Product Code OHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2014
Date Received
August 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Over-The-Counter Hair Removal
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

Over-the-counter device uses thermal energy to kill hair follicles for hair removal.

Other clearances by Wellquest Intl., Inc.

  • K973773 — DAPELLE HAIR REMOVER (December 17, 1997)

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