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510(k) K124042

TANDA MINI SKINCARE SYSTEM by Syneron Beauty — Product Code OLP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2013
Date Received
December 28, 2012
Clearance Type
Special
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 Syneron Beauty

  • K131649 — ME (December 11, 2013)
  • K123845 — ME (January 10, 2013)
  • K122725 — TANDA PEARL, ULTRAWYTE, PEARL (November 27, 2012)

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