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510(k) K801906

DIOPTRON III AUTOREFRACTOR by Coherent Medical Division — Product Code HKO

K801906 is an FDA 510(k) premarket notification submitted by Coherent Medical Division for the device "DIOPTRON III AUTOREFRACTOR". The FDA issued a decision of Substantially Equivalent on August 27, 1980. The device falls under product code HKO (Refractometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760. Coherent Medical Division has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1980
Date Received
August 11, 1980
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 Coherent Medical Division

  • K902990 — COHERENT HOLMIUM:YAG SURGICAL LASER (October 2, 1990)
  • K822908 — COHERENT FUNDUSL RETINAL CAMERA (January 5, 1983)
  • K822415 — THE OCUPLOT D (September 7, 1982)
  • K801336 — MODEL 900K PHOTOCOAGULATOR (July 28, 1980)
  • K791895 — ACCESSORIES FOR SYS. 400 CO2 SURG. LASER (December 20, 1979)

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