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510(k) K843042

VISION TESTER by Stereo Optical Co., Inc. — Product Code HKO

K843042 is an FDA 510(k) premarket notification submitted by Stereo Optical Co., Inc. for the device "VISION TESTER". The FDA issued a decision of Substantially Equivalent on October 5, 1984. The device falls under product code HKO (Refractometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760. Stereo Optical Co., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1984
Date Received
August 2, 1984
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

Other clearances by Stereo Optical Co., Inc.

  • K924741 — OPTEC 3000 (April 6, 1993)
  • K904828 — OPTEC 2300 AFVT, ARMED FORCES VISION TESTER (January 18, 1991)
  • K875237 — OPTEC 1000 DMV VISION TESTER MODIFY (March 17, 1988)
  • K863509 — OPTEC 1000 DMV (November 10, 1986)

Other clearances for product code HKO

  • K031831 — TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM (December 19, 2003)
  • K000327 — WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 (May 2, 2000)
  • K951179 — DIGITAL RETINOSCOPIC PHOTOMETER (May 30, 1995)
  • K945959 — VIDEO VISION ANALYZER (VIVA), VRB 100 (March 1, 1995)
  • K942242 — AUTO REF-KERATOMETER, RK-3 (September 2, 1994)
  • K940516 — AUTO REFF-30 (July 12, 1994)
  • K925304 — AUTOREF LENSMETER RL-10 (February 17, 1994)
  • K924741 — OPTEC 3000 (April 6, 1993)
  • K924778 — BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 (April 5, 1993)
  • K924790 — BURTON AUTO REFRACTOR - MODEL BAR-7 (April 5, 1993)

FDA data resources