Home / 510(k) Clearances / K131719

510(k) K131719

OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS by Medical Devices (Pvt) , Ltd. — Product Code HLJ

K131719 is an FDA 510(k) premarket notification submitted by Medical Devices (Pvt) , Ltd. for the device "OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS". The FDA issued a decision of Substantially Equivalent on October 30, 2013. The device falls under product code HLJ (Ophthalmoscope, Battery-Powered), a Class II device regulated under 21 CFR 886.1570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2013
Date Received
June 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Battery-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances for product code HLJ

  • K142486 — HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 (May 18, 2015)
  • K142837 — HEINE SIGMA 250 & HEINE SIGMA 250 M2 (January 29, 2015)
  • K131959 — HEINE MINI 3000(R) OPHTHALMOSCOPE (March 7, 2014)
  • K131961 — HEINE BETA 200(R) OPHTHALMOSCOPE (December 4, 2013)
  • K123587 — HEINE MINI 3000 LED OPHTHALMOSCOPE (March 22, 2013)
  • K093495 — OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS (November 19, 2010)
  • K070270 — PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 (November 5, 2007)
  • K052599 — 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25 (November 7, 2006)
  • K061278 — OPTYSE OPHTHALMOSCOPE (May 16, 2006)
  • K053425 — PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS (January 9, 2006)

FDA data resources