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510(k) K061278

OPTYSE OPHTHALMOSCOPE by Ophthalmos , Ltd. — Product Code HLJ

K061278 is an FDA 510(k) premarket notification submitted by Ophthalmos , Ltd. for the device "OPTYSE OPHTHALMOSCOPE". The FDA issued a decision of Substantially Equivalent on May 16, 2006. 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
May 16, 2006
Date Received
May 8, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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  • 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)
  • K053425 — PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS (January 9, 2006)

FDA data resources