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510(k) K871611

ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540 by Allergan Humphrey — Product Code HKO

K871611 is an FDA 510(k) premarket notification submitted by Allergan Humphrey for the device "ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540". The FDA issued a decision of Substantially Equivalent on May 18, 1987. The device falls under product code HKO (Refractometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760. Allergan Humphrey has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1987
Date Received
April 10, 1987
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 Allergan Humphrey

  • K902582 — ALLERGAN HUMPHREY A/B SCAN , MODEL 835 (August 14, 1990)
  • K872312 — MODEL 3000 OPHTHALMIC SURGICAL SYSTEM (July 15, 1987)

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