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510(k) K151630

G.o.c.c.l.e.s. by Pierrel Pharma S.R.L. — Product Code NXV

K151630 is an FDA 510(k) premarket notification submitted by Pierrel Pharma S.R.L. for the device "G.o.c.c.l.e.s.". The FDA issued a decision of Substantially Equivalent on September 15, 2015. The device falls under product code NXV (Diagnostic Light, Soft Tissue Detector), a Class II device regulated under 21 CFR 872.6350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2015
Date Received
June 17, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diagnostic Light, Soft Tissue Detector
Device Class
Class II
Regulation Number
872.6350
Review Panel
DE
Submission Type

To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities

Other clearances for product code NXV

  • K123169 — ORALID (March 13, 2013)
  • K121282 — MICROLUX/DL MICROLUX/BLU BIO/SCREEN (July 24, 2012)
  • K102083 — VELSCOPE VX (November 18, 2010)
  • K101140 — DENTLIGHT ORAL EXAM LIGHT KIT (July 15, 2010)
  • K090135 — TRIMIRA IDENTAFI 3000 (February 17, 2009)
  • K082668 — BIO-SCREEN (January 23, 2009)
  • K082603 — TRIMIRA OCS 3000 (December 12, 2008)
  • K080043 — VIZILITE EYEWEAR (April 4, 2008)
  • K073483 — SAPPHIRE O/E ORAL EXAMINATION SYSTEM (April 3, 2008)
  • K070523 — MODIFICATION TO: VELSCOPE (April 5, 2007)

FDA data resources