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510(k) K000327

WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 by Visx, Incorporated — Product Code HKO

K000327 is an FDA 510(k) premarket notification submitted by Visx, Incorporated for the device "WAVESCAN WAVEFRONT SYSTEM MODEL HS 1". The FDA issued a decision of SESU on May 2, 2000. The device falls under product code HKO (Refractometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760. Visx, Incorporated has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESU ()
Decision Date
May 2, 2000
Date Received
February 2, 2000
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 Visx, Incorporated

  • K043503 — VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 (April 5, 2005)

Other clearances for product code HKO

  • K031831 — TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM (December 19, 2003)
  • 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)
  • K904828 — OPTEC 2300 AFVT, ARMED FORCES VISION TESTER (January 18, 1991)

FDA data resources