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510(k) K951179

DIGITAL RETINOSCOPIC PHOTOMETER by Kudi Kalu, Inc. — Product Code HKO

K951179 is an FDA 510(k) premarket notification submitted by Kudi Kalu, Inc. for the device "DIGITAL RETINOSCOPIC PHOTOMETER". The FDA issued a decision of Substantially Equivalent on May 30, 1995. The device falls under product code HKO (Refractometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1995
Date Received
March 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refractometer, Ophthalmic
Device Class
Class I
Regulation Number
886.1760
Review Panel
OP
Submission Type

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  • K925304 — AUTOREF LENSMETER RL-10 (February 17, 1994)
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  • K924790 — BURTON AUTO REFRACTOR - MODEL BAR-7 (April 5, 1993)
  • K904828 — OPTEC 2300 AFVT, ARMED FORCES VISION TESTER (January 18, 1991)

FDA data resources