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510(k) K854968

BAUSCH & LOMB LENS CARRYING CASE by Bausch & Lomb, Inc. — Product Code HPX

K854968 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "BAUSCH & LOMB LENS CARRYING CASE". The FDA issued a decision of Substantially Equivalent on April 4, 1986. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1986
Date Received
December 11, 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 Bausch & Lomb, Inc.

  • K261264 — Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pac (May 15, 2026)
  • K232084 — Stellaris Elite vision enhancement system (February 26, 2024)
  • K192005 — Bausch + Lomb PreVue Inserter for enVista Preloaded (October 4, 2019)
  • K173480 — Crystalsert Lens Delivery System (December 11, 2017)
  • K151102 — Bausch + Lomb Injector System (May 22, 2015)
  • K133486 — STELLARIS PC VISION ENHANCEMENT SYSTEM (March 12, 2014)
  • K133242 — STELLARIS VISION ENHANCEMENT SYSTEM (February 14, 2014)
  • K131958 — BAUSCH & LOMB INJECTOR SYSTEM (January 9, 2014)
  • K133146 — BAUSCH + LUMB, VIS100 INJECTOR SYSTEM (January 3, 2014)
  • K132481 — EASY-LOAD LENS DELIVERY SYSTEM (December 27, 2013)

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