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510(k) K800192

DURALITE LENS by American Optical Corp. — Product Code HPX

K800192 is an FDA 510(k) premarket notification submitted by American Optical Corp. for the device "DURALITE LENS". The FDA issued a decision of Substantially Equivalent on March 12, 1980. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device. American Optical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1980
Date Received
January 29, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Polymethylmethacrylate)
Device Class
Class U
Regulation Number
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)
  • K931358 — AORP4000 REUSABLE PAK (February 22, 1994)
  • K931354 — P4000 PHACOEMULSIFIER (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 HPX

  • K955777 — PMMA CLASIC (May 16, 1996)
  • K940106 — KERATOPLASTY SUTURING LENS (May 25, 1994)
  • K913081 — MULTI-VIEW BIFOCALS (October 23, 1991)
  • K897021 — MARTIN-HENSLEY SEGMENT LENS (June 22, 1990)
  • K895411 — OPTIKEM PMMA CONTACT LENS (February 27, 1990)
  • K874591 — ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY (May 3, 1988)
  • K865111 — CHARTER HARD CONTACT LENS CLEANING SOLUTION (January 20, 1987)
  • K864343 — BL1 (HARD CONTACT LENS) (November 28, 1986)
  • K863974 — CHARTER LABORATORIES INC. LENS LUBRICANT (November 10, 1986)
  • K862952 — CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES (September 25, 1986)

FDA data resources