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510(k) K904828

OPTEC 2300 AFVT, ARMED FORCES VISION TESTER by Stereo Optical Co., Inc. — Product Code HKO

K904828 is an FDA 510(k) premarket notification submitted by Stereo Optical Co., Inc. for the device "OPTEC 2300 AFVT, ARMED FORCES VISION TESTER". The FDA issued a decision of Substantially Equivalent on January 18, 1991. 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
January 18, 1991
Date Received
October 24, 1990
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)
  • K875237 — OPTEC 1000 DMV VISION TESTER MODIFY (March 17, 1988)
  • K863509 — OPTEC 1000 DMV (November 10, 1986)
  • K843042 — VISION TESTER (October 5, 1984)

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)
  • K924790 — BURTON AUTO REFRACTOR - MODEL BAR-7 (April 5, 1993)
  • K924778 — BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 (April 5, 1993)

FDA data resources