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510(k) K802183

SR-IV PROGRAMMED SUBJECTIVE REFRACTOR by American Optical Corp. — Product Code HKO

K802183 is an FDA 510(k) premarket notification submitted by American Optical Corp. for the device "SR-IV PROGRAMMED SUBJECTIVE REFRACTOR". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code HKO (Refractometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760. American Optical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1981
Date Received
September 9, 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 American Optical Corp.

  • K950881 — PHACO TIP (September 6, 1995)
  • K950880 — AOI UNIVERSAL ULTRASONIC HANDPIECE (May 26, 1995)
  • K931354 — P4000 PHACOEMULSIFIER (February 22, 1994)
  • K931358 — AORP4000 REUSABLE PAK (February 22, 1994)
  • K931357 — AOD4000 DISPOSABLE PAK (January 25, 1994)
  • K820790 — FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 (April 1, 1982)
  • K813430 — TISSUE PROCESSING CASSETTES & ACCESS (December 29, 1981)
  • K812965 — MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE (November 2, 1981)
  • K812051 — PHOTOLITE AOLITE TINTOMATIC LENS (September 8, 1981)
  • K812063 — SR-1V DATA PRINTER (August 18, 1981)

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