Home / 510(k) Clearances / K850909

510(k) K850909

RHODA-LUX LENS BLANKS by Optatint, Inc. — Product Code HPX

K850909 is an FDA 510(k) premarket notification submitted by Optatint, Inc. for the device "RHODA-LUX LENS BLANKS". The FDA issued a decision of Substantially Equivalent on October 4, 1985. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device. Optatint, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1985
Date Received
March 5, 1985
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 Optatint, Inc.

  • K854442 — UVASORB-400 (February 19, 1986)

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