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510(k) K091829

PLS PORTABLE LIGHT SOURCE by Optim, Inc. — Product Code NTN

K091829 is an FDA 510(k) premarket notification submitted by Optim, Inc. for the device "PLS PORTABLE LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on July 28, 2009. The device falls under product code NTN (Led Light Source), a Class II device regulated under 21 CFR 876.1500. Optim, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2009
Date Received
June 19, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Led Light Source
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals

Other clearances by Optim, Inc.

  • K254133 — ENTity USB Videoscope System (May 14, 2026)
  • K200609 — ENTity WiFi Video Nasopharyngoscope System (January 13, 2021)
  • K130489 — ELECTRODE, FLEXIBLE SUCTION COAGULATOR (April 19, 2013)
  • K122593 — PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI- (September 13, 2012)
  • K080622 — ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 (April 2, 2008)

Other clearances for product code NTN

  • K141164 — ARTEMIS LIGHT ENGINE (March 16, 2015)
  • K133311 — ENDOLED (July 30, 2014)
  • K130819 — CLL- V1 LIGHT SOURCE (June 19, 2013)
  • K122831 — VIDEO SYSTEM CENTER (December 14, 2012)
  • K113679 — LUCEA LED SURGICAL LIGHT SYSTEM (January 12, 2012)
  • K103813 — SOPRO 281 (March 22, 2011)
  • K102167 — LO-50 LED LIGHT SOURCE (August 17, 2010)
  • K090601 — FSC 2 (May 11, 2009)

FDA data resources