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510(k) K112362

C100 WRINKLE REDUCTION DEVICE by Silver Bay, LLC — Product Code OHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2012
Date Received
August 17, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Over The Counter Wrinkle Reduction
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.

Other clearances by Silver Bay, LLC

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  • K091467 — BABY QUASAR (September 17, 2010)
  • K093963 — QUASAR BLUE LIGHT THERAPY SYSTEM (August 27, 2010)
  • K072767 — QUASAR BLUE LIGHT THERAPY SYSTEM (October 15, 2007)

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