Home / 510(k) Clearances / K102083

510(k) K102083

VELSCOPE VX by Led Dental, Inc. — Product Code NXV

K102083 is an FDA 510(k) premarket notification submitted by Led Dental, Inc. for the device "VELSCOPE VX". The FDA issued a decision of Substantially Equivalent on November 18, 2010. The device falls under product code NXV (Diagnostic Light, Soft Tissue Detector), a Class II device regulated under 21 CFR 872.6350. Led Dental, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2010
Date Received
July 26, 2010
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 by Led Dental, Inc.

  • K153710 — Tuxedo Digital Dental Sensor (March 18, 2016)
  • K070523 — MODIFICATION TO: VELSCOPE (April 5, 2007)

Other clearances for product code NXV

  • K151630 — G.o.c.c.l.e.s. (September 15, 2015)
  • K123169 — ORALID (March 13, 2013)
  • K121282 — MICROLUX/DL MICROLUX/BLU BIO/SCREEN (July 24, 2012)
  • 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