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510(k) K131939

AMICO DH-W35 OPHTHALMOSCOPE SERIES by Amico Diagnostic Incorporated — Product Code HLI

K131939 is an FDA 510(k) premarket notification submitted by Amico Diagnostic Incorporated for the device "AMICO DH-W35 OPHTHALMOSCOPE SERIES". The FDA issued a decision of Substantially Equivalent on March 26, 2014. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2014
Date Received
June 27, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT (April 23, 2014)
  • K133892 — IVUE 500 (March 19, 2014)
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  • K121739 — IVUE WITH NORMATIVE DATABASE (January 18, 2013)
  • K120057 — ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (May 11, 2012)
  • K120238 — RTVUE XR OCT (April 3, 2012)

FDA data resources