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510(k) K861643

STYLEKEEPER CONTACT LENS CARRYING CASE by Allergan, Inc. — Product Code HPX

K861643 is an FDA 510(k) premarket notification submitted by Allergan, Inc. for the device "STYLEKEEPER CONTACT LENS CARRYING CASE". The FDA issued a decision of Substantially Equivalent on June 2, 1986. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device. Allergan, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1986
Date Received
April 30, 1986
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 Allergan, Inc.

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  • K193589 — TrueTear Intranasal Tear Neurostimulator (August 31, 2020)
  • K190674 — REFRESH RELIEVA For CONTACTS (August 8, 2019)
  • K180826 — Natrelle 133 Plus MICROCELL Tissue Expander (December 21, 2018)
  • K182054 — Natrelle 133S Tissue Expander (August 29, 2018)
  • DEN170086 — TrueTear Intranasal Tear Neurostimulator (May 17, 2018)
  • K161457 — XEN Glaucoma Treatment System (November 21, 2016)
  • K143354 — Natrelle 133 Plus Tissue Expander (August 20, 2015)
  • K123128 — SERI SURGICAL SCAFFOLD (April 25, 2013)
  • K083812 — REFRESH OPTIVE LENS COMFORT REWETTING DROPS (July 9, 2009)

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