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510(k) K093963

QUASAR BLUE LIGHT THERAPY SYSTEM by Silver Bay, LLC — Product Code OLP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2010
Date Received
December 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Over-The-Counter Powered Light Based Laser For Acne
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.

Other clearances by Silver Bay, LLC

  • K112362 — C100 WRINKLE REDUCTION DEVICE (August 14, 2012)
  • K111286 — QUASAR CALYPSO (January 18, 2012)
  • K091467 — BABY QUASAR (September 17, 2010)
  • K072767 — QUASAR BLUE LIGHT THERAPY SYSTEM (October 15, 2007)

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