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510(k) K122725

TANDA PEARL, ULTRAWYTE, PEARL by Syneron Beauty — Product Code EEG

K122725 is an FDA 510(k) premarket notification submitted by Syneron Beauty for the device "TANDA PEARL, ULTRAWYTE, PEARL". The FDA issued a decision of Substantially Equivalent on November 27, 2012. The device falls under product code EEG (Heat Source For Bleaching Teeth), a Class I device regulated under 21 CFR 872.6475. Syneron Beauty has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2012
Date Received
September 5, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heat Source For Bleaching Teeth
Device Class
Class I
Regulation Number
872.6475
Review Panel
DE
Submission Type

Other clearances by Syneron Beauty

  • K131649 — ME (December 11, 2013)
  • K124042 — TANDA MINI SKINCARE SYSTEM (April 2, 2013)
  • K123845 — ME (January 10, 2013)

Other clearances for product code EEG

  • K110888 — ABSOLUTE WHITE LIGHT (January 12, 2012)
  • K063704 — BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 (February 20, 2007)
  • K052040 — QUICKSMILE (October 18, 2005)
  • K041392 — SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US (November 8, 2004)
  • K042153 — SOUTH BEACH SMILE LIGHT WHITENING SYSTEM (November 8, 2004)
  • K895174 — UNION BROACH BLEACHING LIGHT (April 13, 1990)
  • K884937 — BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING (April 14, 1989)
  • K862385 — SCHEIN BLEACHING UNIT (October 30, 1986)
  • K854692 — MONARCH II BLEACHING INSTRUMENT (May 12, 1986)
  • K832179 — HOT PROBE MODEL 6001 (October 4, 1983)

FDA data resources