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510(k) K142837

HEINE SIGMA 250 & HEINE SIGMA 250 M2 by Heine Optotechnik GmbH & Co. KG — Product Code HLJ

K142837 is an FDA 510(k) premarket notification submitted by Heine Optotechnik GmbH & Co. KG for the device "HEINE SIGMA 250 & HEINE SIGMA 250 M2". The FDA issued a decision of Substantially Equivalent on January 29, 2015. The device falls under product code HLJ (Ophthalmoscope, Battery-Powered), a Class II device regulated under 21 CFR 886.1570. Heine Optotechnik GmbH & Co. KG has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2015
Date Received
September 30, 2014
Clearance Type
Abbreviated
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 by Heine Optotechnik GmbH & Co. KG

  • K142486 — HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 (May 18, 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)
  • K123316 — HEINE OMEGA 500 (February 26, 2013)
  • K101892 — HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL (August 27, 2010)

Other clearances for product code HLJ

  • K142486 — HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 (May 18, 2015)
  • K131959 — HEINE MINI 3000(R) OPHTHALMOSCOPE (March 7, 2014)
  • K131961 — HEINE BETA 200(R) OPHTHALMOSCOPE (December 4, 2013)
  • K131719 — OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS (October 30, 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